natgillin/translations-raw huggingface dataset:
All products are aqueous solutions and contain a solubilising agent, such as potassium hydroxide or acetic acid, a preservative such as benzyl alcohol, and are made up to volume with water; thus there are no indications that formulation differences can account for the variability seen between the studies provided.
Svi proizvodi su vodene otopine i sadrže topljiva sredstva, poput kalijevog hidroksida ili acetilne kiseline, konzervanse, poput benzilnog alkohola, i povećavaju se u volumenu kada se miješaju s vodom.
Industrial Veterinaria S.A. Esmeralda, 19
Španjolska Industrial Veterinaria S.A. Esmeralda, 19
Eleven references were submitted, two of which were dated after 2000, in support of the indication for Mycoplasma spp.
U prilog indikaciji za Mycoplasma spp dostavljeno je jedanaest referenci, od kojih su dvije datirane nakon 2000. godine.
Two studies conducted in 1997 and 2002 both demonstrated that when birds were infected with E.coli with reduced susceptibility, MIC=0.5 µg/ml, the efficacy of 10 mg/kg enrofloxacin was reducedclinical signs were less well controlled and in one study mortality was approximately 43%.
Provedena su dva ispitivanja 1997. i 2002. od kojih su oba demonstrirala da je djelotvornost od 10 mg/kg enrofloksacina smanjena - klinički su znakovi bili slabije kontrolirani, a u jednom je ispitivanju smrtnost iznosila otprilike 43% - u slučaju kada su ptice inficirane E.coli sa smanjenom osjetljivošću, MIC=0.5 µg/ml.
s.r.o., Murgašova 5, 949 01 Nitra Slovak Republic
Pharmagal spol. s.r.o., Murgašova 5, 949 01 Nitra Slovačka
Taking account of all the data, the indication for the treatment of P.multocida in turkeys is acceptable at a dose of 10 mg/kg bw for 35 days.
Uzimajući u obzir sve podatke, indikacija za liječenje P.multocida u purana prihvatljiva je u dozama od 10 mg/kg tjelesne težine za 3 - 5 dana.
Krka d.d.
Rákóczi u.
Solution for use in drinking water.
Otopina za uporabi u vodi za piće.
One field study was submitted to support the indication of P.multocida using an inclusion rate of
Dostavljeno je jedno terensko ispitivanje u prilog indikaciji P.multocida primjenom inkluzijske stope od 50 ppm.
In a recent study from Italy, Russo et al. (2012) found that 30.34% of eighty-nine APEC (avian pathogenic E. coli) isolates from turkeys were classified as resistant to enrofloxacin and 40.45% as intermediately resistant with a breakpoint of 2 µg/ml.
U nedavnom ispitivanju provedenom u Italiji, Russo et al. (2012.) utvrđeno je da je 30,34% od osamdesetdevet izolata APEC-a (ptičje patogene E. coli) iz purana klasificirano kao otporni na enrofloksacin, a 40,45% kao neposredno otporni s graničnom vrijednosti od 2 µg/ml.
A report by Sellyei et al, 20094, advised that although P.multocida isolates are susceptible to most widely used antimicrobials, remarkable resistance was detected to sulphonamides, tetracyclines, first generation quinolones and aminoglycosides.
U izvješću Sellyei et al, 2009.4 savjetovano je da je otkrivena značajna otpornost na sulfonamide, tetracikline, kinolone prve generacije i aminoglikozide, iako su izolati P.multocida osjetljivi na većinu široko primijenjenih antimikrobnih sredstava.
Adequate data have been submitted to support indications for M.gallisepticum, M.synoviae, A.paragallinarium, P.multocida and E.coli in chickens and M.gallisepticum, M.synoviae, P.multocida and E.coli in turkeys.
Dostavljeni su primjereni podaci u prilog indikacijama za M.gallisepticum, M.synoviae, A.paragallinarium, P.multocida i E.coli u pilića te M.gallisepticum, M.synoviae, P.multocida i E.coli u purana.
Animal species
Put primjene Životinjske vrste
In a recent study from Italy, Russo et al. (2012)10 found that 30.34% of eighty-nine APEC (avian pathogenic E. coli) isolates from turkeys were classified as resistant to enrofloxacin and 40.45% as intermediately resistant with a breakpoint of 2 µg/ml.
U novijem ispitivanju iz Italije, Russo et al. (2012.)10 utvrđeno je da je 30,34% od osamdesetdevet izolata APEC-a (ptičjih patogenih E. coli) iz purana klasificirano kao otporno na enrofloksacin, a 40,45% kao neposredno otporni s graničnom vrijednosti od 2 µg/ml.
Romania DIVASA - FARMAVIC, S.A. Ctra Sant Hipolit Km 71
Rumunjska DIVASA - FARMAVIC, S.A. Ctra Sant Hipolit
La Selva, 135, 17170 Amer (Girona) Spain
La Selva, 135, 17170 Amer (Girona) Španjolska
La Selva 135, 17170 - Amer (Girona) Spain
La Selva 135, 17170 - Amer (Girona) Španjolska
Romania Laboratorios Syva, s.a.u, Avenue Parroco Pablo Diez
Rumunjska Laboratorios Syva, s.a.u, Avenue Parroco Pablo Diez
La Selva 135, 17170 Amer (Girona) Spain
La Selva 135, 17170 Amer (Girona) Španjolska
Enrofloxacin 0,5% Solution for oral use
Enrofloxacin 0,5% Otopina za peroralnu uporabu
Romania Lavet Pharmaceuticals Ltd., Ottó u. 14.,
Rumunjska Lavet Pharmaceuticals Ltd., Ottó u.
It is therefore proposed that a new dosing regimen should be elaborated that takes into account the evolution of the susceptibility profile of E. coli since enrofloxacin was first authorised in poultry and new PK/PD concepts aimed at limiting development of resistance in target pathogens.
Stoga je predložena izrada novog režima doziranja koji uzima u obzir ocjenu profila osjetljivosti E. coli od trenutka kada je enrofloksacina prvi put odobren za primjenu u peradi, a novi farmakokinetički i farmakodinamički koncepti usmjereni su na ograničavanje razvoja otpornosti u ciljnih patogena.
Chicken broiler
Brojler pilići
Netherlands aniMedica GmbH, Im Südfeld 9,
Nizozemska aniMedica GmbH, Im Südfeld 9,
Therefore in order to take into account the evolution of the susceptibility profiles of E.coli since enrofloxacin was first authorised in poultry, and new PK/PD concepts, a population PK/PD analysis is needed to optimise the dosing regimen.
Stoga kako bi se u obzir uzela evolucija profila osjetljivosti E.coli s obzirom da je enrofloksacin prvi put odobren u peradi, a novi farmakokinetički i farmakodinamički koncepti te farmakokinetička i farmakodinamička analiza populacije potrebni su kako bi se optimizirao režim doziranja.
C/Capcanes, 12-bajos Poligono Agro-Reus 43206-Reus Tarragona
Global Vet Health S.L. C/Capcanes, 12-bajos Poligono Agro-Reus 43206-Reus Tarragona
Poultry (broilers), bovine (calves), pigs
Perad (brojleri), goveda (telad), svinje
Romania Hipra Laboratorios Avda.
Rumunjska Hipra Laboratorios Avda.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Chickens and turkeys
DOZIRANJE ZA SVAKU VRSTU, PUTOVI I NAČINI PRIMJENE Pilići i purani
Amendments in the relevant sections of the summaries of product characteristics, labelling and package leaflets
Izmjene odgovarajućih dijelova sažetaka opisa svojstava, etiketa i uputa o lijeku
Romania UNIVERSAL PHARMA Gran Via Carlos III 98-7a 08028-Barcelona
Rumunjska UNIVERSAL PHARMA Gran Via Carlos III 98-7a 08028-Barcelona
Lithuania Lavet Pharmaceuticals Ltd., Ottó u. 14.,
Mađarska Lavet Pharmaceuticals Ltd., Ottó u.
Crta de Castellvell, 24 43206 Reus (Tarragona) Spain
43206 Reus (Tarragona) Španjolska
Chickens, pigs and turkeys
Pilići, svinje i purani
A comprehensive PK/PD analysis was provided.
Dostavljena je opsežna farmakokinetička i farmakodinamička analiza.
Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010.
European Food Safety Authority and European Centre for Disease Prevention and Control; The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010.
Prodivet-Zn, Nutrição e Comércio de Produtos Químicos, Farmacêuticos e Cosméticos, SA Av. Infante D. Henrique nº333 H 3º Piso Esc. 41 1800-282 Lisboa Portugal
Henrique nº333 H 3º Piso Esc. 41 1800-282 Lisboa Portugal
Novo mesto, Šmarjeska cesta 6
Mađarska Krka d.d. Novo mesto, Šmarjeska cesta 6
Arciucha 2, 24-100 Puławy Poland
Biowet Puławy Sp. z o.o. ul. Arciucha 2, 24-100 Puławy Poljska
Chicken - broilers and rabbits
Pilići - brojleri i kunići
Chicken and pigeon
Pilići i golubovi
• the CVMP considered that in order to take into account the evolution of the susceptibility profiles of E.coli since enrofloxacin was first authorised in poultry, and new PK/PD concepts, the dosing regimen should be optimised for efficacy and to limit the potential for further development of resistance in target pathogens;
• CVMP je zaključio da se režimi doziranja trebaju optimizirati u smislu djelotvornosti i kako bi se u obzir mogla uzeti evolucija profila osjetljivosti E.coli s obzirom da je enrofloksacin prvi put odobren u peradi kao i novi farmakokinetički i farmakodinamički koncepti, te kako bi se ograničio potencijal za daljnji razvoj otpornosti u ciljnih patogena.
CHEMO IBÉRICA, S.A. Gran Vía Carlos III 98 - 7a, 08028 Barcelona Spain
Španjolska CHEMO IBÉRICA, S.A. Gran Vía Carlos III 98 - 7a, 08028 Barcelona
Vetoquinol Biowet Sp.
Vetoquinol Biowet Sp. z.o.o., ul.
Germany aniMedica GmbH, Im Südfeld 9,
Njemačka aniMedica GmbH, Im Südfeld 9,
Ceva Animal Health Slovakia, spol s r.o., Račianska 77, 831 02 Bratislava, Slovakia
Slovačka Ceva Animal Health Slovačka, spol s r.o., Račianska 77,
Chicken, turkey and pigeon
Pilići, purani i golubovi
• the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see annex I), subject to amendments in the product information and conditions on the marketing authorisations; the CVMP has recommended the variations of the marketing authorisations for the veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see annex I of the opinion) in order to amend the summaries of product characteristics, labelling and package leaflets as set out in annex III.
CVMP je preporučio izmjene odobrenja za stavljanje VMP-a u promet za veterinarsko-medicinske lijekove koji sadrže enrofloksacin za primjenu putem vode za piće u pilića i/ili purana (vidjeti Prilog I. mišljenja) kako bi se izmijenili sažetci opisa svojstava VMP-a, etikete i upute o lijeku kako je navedeno u Prilogu III.
Both proprietary and published data were provided to form a picture of the depletion of residues from edible tissues resulting from treatment with enrofloxacin-containing, orally-administered veterinary
Dostavljeni su kako vlasnički tako i objavljeni podaci kako bi se stvorila slika o razgradnji rezidua iz jestivih tkiva nastalih zbog liječenja veterinarsko-medicinskim proizvodima koji sadrže enrofloksacin i primjenjuju se peroralno u dozi od 10 mg/kg tjelesne težine/danu tijekom 5 uzastopnih dana u pilića i purana.
Baytril 100 mg/mlLösung zum Eingeben für Hühner und Puten
Baytril 100 mg/ml - Lösung zum Eingeben für Hühner und Puten
Poultry (broilers and fattened turkeys), rabbits
Perad (brojleri i utovljeni purani), kunići
Romania Vetoquinol Biowet Sp.
Rumunjska Vetoquinol Biowet Sp. z.o.o., ul.
Netherlands S.P. VETERINARIA, S.A. Ctra.
Nizozemska S.P. VETERINARIA, S.A. Ctra.
A study by Haritova et al (2011)11 demonstrated that when E.coli O78/H12 infected chickens (MIC 0.01 µg/ml) were treated with either 10 mg/kg bw or 50 mg/kg bw enrofloxacin for 3 days, both dose
Ispitivanje provedeno od strane Haritova et al (2011.)11 pokazalo je da kada su pilići inficirani E.coli O78/H12 (MIC 0.01 µg/ml) tretirani s 10 mg/kg tjelesne težine ili 50 mg/kg tjelesne težine enrofloksacina tijekom 3 dana, obje su doze kontrolirale kliničke znakove, no do 25. dana nakon infekcije, patogen je još uvijek bio ponovno izoliran u slezeni u grupi koja je primala 50 mg/kg tjelesne težine u usporedbi s ponovnom izolacijom iz pluća, jetre, srca i slezene u grupi koja je primila 10 mg/kg tjelesne težine.
Pigs, calves, chicken (broilers), turkeys
Svinje, telad, pilići (brojleri), purani
Concentrate for oral solution for use in drinking water
Koncentrat za peroralnu otopinu za primjenu u vodi za piće
Poultry, pigs
Perad, svinje
11-500 Giżycko
Bialostocka 12, 11-500 Giżycko Poljska
Grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Osnove za izmjenu sažetaka svojstava opisa VMP-a, etiketa i uputa o VMP-u
The one reference conducted in the EU
Jedina referenca
Poultry and pigs
Perad i svinje
C/Capcanes, 12-bajos Poligono Agro-Reus 43206-Reus
Francuska Global Vet Health S.L. C/Capcanes, 12-bajos Poligono Agro-Reus 43206-Reus
Dolgos u. 2., 1126 Budapest, Hungary
1126 Budapest, Mađarska
Bayer Animal Health GmbH, 51368 Leverkusen, Germany
Bayer Animal Health GmbH, 51368 Leverkusen, Njemačka
Russo, E., Lucatello, L., Giovanardi, D., Cagnardi, P., Ortali, G., Di Leva, V., Montesissa, C. (2012).
ISBN 978-3-00-031622-7. http://www.bvl.bund.de/SharedDocs/Downloads/08_PresseInfothek/Germap_2010.pdf?__blob=publicationFile&v=2. 10 Russo, E., Lucatello, L., Giovanardi, D., Cagnardi, P., Ortali, G., Di Leva, V., Montesissa, C. (2012).
Enrofloxacin 10 % w/v Concentrate for oral solution
Enrofloxacin 10 % w/v Koncentrat za peroralnu otopinu
Pig, chicken (broilers and laying hens) and pigeon
Svinje, pilići (brojleri i nesilice) i golubovi
Ireland Universal Farma, S.L., Gran Via Carlos III, 98-7a, 08028 Barcelona
Universal Farma, S.L., Gran Via Carlos III, 98-7a, 08028 Barcelona
Oral solution for use in drinking water
Peroralna otopina za uporabu u vodi za piće
Solution for use in water
Otopina za primjenu u vodi
LABORATORIOS E INDUSTRIAS IVEN, S.A. C/Luis I 56
Španjolska LABORATORIOS E INDUSTRIAS IVEN, S.A.
Bayer Animal Health GmbH 51368 Leverkusen Germany
Bayer Animal Health GmbH 51368 Leverkusen Njemačka
Enrofloxacin 10% Solution for oral use
Enrofloxacin 10% Otopina za peroralnu uporabu
Broilers, rearing poultry, turkeys
Brojleri, rasplodna perad, purani
Netherlands Vetpharma Animal Health S.L.,
Nizozemska Vetpharma Animal Health S.L.,
Cattle (calves), pigs, chicken (broilers), cats, dogs
Goveda (telad), svinje, pilići (brojleri), mačke, psi
VMD Állatgyógyászati Kft. Közraktár u. 22/b.
Mađarska VMD Állatgyógyászati Kft.
Poultry, rabbits
Pilići, kunići
Romania Bayer Animal Health GmbH, 51368 Leverkusen,
Rumunjska Bayer Animal Health GmbH, 51368 Leverkusen,
Chicken, turkey, pigeons, cattle, swine, dogs and cats
Pilići, purani, golubovi, goveda, svinje, psi i mačke
Belgium S.P. VETERINARIA, S.A. Ctra.
Španjolska S.P. VETERINARIA, S.A. Ctra.
Germany Laboratorios Hipra S.A. Avda.
Njemačka Laboratorios Hipra S.A. Avda.
Cattle, pig, dog, chicken, turkey and pigeon
Goveda, svinje, psi, pilići, purani i golubovi
4.9 Amount(s) to be administered and administration route Chickens and turkeys
4.9 Količine koje se primjenjuju te putu primjene Pilići i purani
Calves, pigs, dogs, cats, chickens (broilers), pigeons
Goveda, svinje, psi, mačke, pilići (brojleri), golubovi
1107 Budapest, Hungary
1107 Budapest,
Solution for use in drinking water
Otopina za uporabi u vodi za piće
Universal Farma, S.L., Gran Via Carlos III 98 - 7a, 08028 Barcelona Spain
Španjolska Universal Farma, S.L., Gran Via Carlos III 98 - 7a, 08028 Barcelona
Chickens and rabbits
Pilići i kunići
Germany Vetpharma Animal Health S.L.,
Njemačka Vetpharma Animal Health S.L.,
Netherlands Laboratorios Karizoo S.A., Pol. Ind. La Borda,
Nizozemska Laboratorios Karizoo S.A., Pol.
Swine, cattle (calves), broiler chickens, dogs, cats
Svinje, goveda (telad), brojler pilići, psi, mačke
Chickens Rabbits
Pilići Kunići
Chicken, cattle, swine, pigeons, dogs and cats
Pilići, goveda, svinje, golubovi, psi i mačke
Lithuania Laboratorios Hipra S.A. Avda.
Slovačka Laboratorios Hipra S.A. Avda.
Chicken (broilers, broiler parent animals, pullets), rabbit
Pilići (brojleri, roditelji brojlera, mlade kokoši), kunići
Chickens (broilers)
Perad (brojleri)
Denmark Bayer Animal Health GmbH, 51368 Leverkusen,
Bugarska Bayer Animal Health GmbH, 51368 Leverkusen,
Chicken broilers, turkey
Brojler pilići, purani
Germany Laboratorios Karizoo S.A., Pol. Ind. La Borda,
Njemačka Laboratorios Karizoo S.A., Pol.
Chicken and turkeys
Pilići - brojleri i purani
Chickens (broilers, broiler breeders, replacement chickens), turkeys
Pilići (brojleri, uzgojni brojleri, zamjenski pilići), purani
Enrofloxacin 100 g/ 1L Oral solution.
Enrofloxacin 100 g/ 1L Peroralna otopina.
Chickens, turkeys, guinea fowl, ducks, pheasant, quails, rabbits
Pilići, purani, biserke, patke, fazani, prepelice, kunići
Belgium Laboratorios Karizoo S.A., Pol. Ind. La Borda,
Španjolska Laboratorios Karizoo S.A., Pol.
Chicken, cattle, pig, dog, cat and pigeon
Pilići, goveda, svinje, psi, mačke i golubovi
Poultry, non egglayers
Perad koja ne nese jaja
Poultry (broilers, replacement chickens, broiler breeders and turkeys)
Pilići (brojleri, zamjenski pilići, uzgojni brojleri) i purani
Netherlands Krka d.d.
Nizozemska Krka d.d. Novo mesto, Šmarjeska cesta 6
Chickens (broilers, replacement chickens, broiler breeders) and rabbits
Pilići (brojleri, zamjenski pilići, uzgojni brojleri) i kunići
Oral solution to be administered in drinking water
Peroralna otopina za primjenu u vodi za piće
POLICHEM, S.A.
Petrov, and L.
Poultry (broilers and broiler breeders)
Perad (brojleri i uzgojni brojleri)
Chickens, turkeys, rabbits
Pilići, purani, kunići
Lithuania Vetoquinol Biowet Sp.
Mađarska Vetoquinol Biowet Sp. z.o.o., ul.
Chicken (broilers, replacement chickens, broiler breeders), rabbit
Pilići (brojleri, zamjenski pilići, uzgojni brojleri), kunići
Calves, lambs, kids, piglets, poultry, dogs, cats
Goveda, janjad, mlado, praščići, perad, psi, mačke
Pigs, calves, lambs, kids, poultry (chicken and turkey)
Svinje, goveda, janjad, mlado, perad (pilići i purani)
enrofloksacyna 100 mg/ml roztwór doustny dla kur, indyków i gołębi
ENROFLOKSACYN A 10%, enrofloksacyna 100 mg/ml roztwór doustny dla kur, indyków i gołębi
Chickens (broilers, replacement chickens, broiler breeders) and turkeys
Perad (brojleri, zamjenski pilići, uzgojni brojleri) i purani
Chickens, turkeys and rabbits
Pilići, purani i kunići
Broiler chicken, non-ruminating calves and pigs
Brojler pilići, telad hranjena formulom i svinje
Belgium Vetpharma Animal Health S.L.,
Slovačka Vetpharma Animal Health S.L.,
Solution for oral use
Otopina za peroralnu uporabu
Virbac
Perad
Entecavir Accord is taken once a day.
Entekavir Accord uzima se jednom dnevno.
It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.
Može se razmotriti i primjena u djece u dobi od 2 do 18 godina, ali samo u one s kompenziranom bolešću jetre.
The full EPAR for Entecavir Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Entekavir Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
When treatment is considered appropriate in children, the dose depends on their body weight.
Kada se liječenje smatra primjerenim u djece, doza ovisi o njihovoj tjelesnoj težini.
The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal.
Doza od 0,5 mg može se uzimati s hranom ili bez nje, ali doza od 1 mg mora se uzeti najmanje 2 sata prije ili 2 sata nakon obroka.
This means that Entecavir Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Baraclude.
To znači da Entekavir Accord sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Baraclude.
The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.
Dnevna doza od 1 mg primjenjuje se i u odraslih bolesnika s dekompenziranom bolešću jetre te se prestanak liječenja u ovih bolesnika ne preporučuje.
Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Entekavir zaustavlja virus u stvaranju DNK-a te sprječava njegovo razmnožavanje i širenje.
Entecavir Accord can only be obtained with a prescription and is available as tablets (0.5 mg and 1 mg).
Entekavir Accord izdaje se samo na liječnički recept i dostupan je u obliku tableta (od 0,5 mg i 1 mg).
What measures are being taken to ensure the safe and effective use of Entecavir Accord?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Entekavir Accord?
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).
Primjenjuje se u odraslih sa znakovima kontinuiranog oštećenja jetre (poput upale i fibroze) u slučaju kada jetra još uvijek ispravno radi (kompenzirana bolest jetre) te kada jetra više ne radi ispravno (dekompenzirana bolest jetre).
Entecavir Accord is a medicine used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Entekavir Accord je lijek koji se koristi za liječenje kroničnog (dugotrajnog) hepatitisa B (infektivne bolesti jetre koju uzrokuje virus hepatitisa B).
As for every medicine, the company provided studies on the quality of Entecavir Accord.
Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Entekavir Accord.
Treatment with Entecavir Accord should be started by a doctor with experience in the management of chronic hepatitis B.
Liječenje lijekom Entekavir Accord treba započeti liječnik s iskustvom u liječenju kroničnog hepatitisa B.
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.
Bolesnici koji nisu prethodno liječeni analogom nukleozida primaju dozu od 0,5 mg, a oni prethodno liječeni lamivudinom u kojih infekcija više ne odgovara na ovaj lijek primaju dozu od 1 mg.
This is a summary of the European public assessment report (EPAR) for Entecavir Accord.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Entekavir Accord.
Because Entecavir Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je Entekavir Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
What is Entecavir Accord and what is it used for?
Što je Entekavir Accord i za što se koristi?
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Baraclude, and do not need to be repeated for Entecavir Accord.
Ispitivanja o koristima i rizicima djelatne tvari pri odobrenim primjenama već su provedena za referentni lijek Baraclude te ih ne treba ponavljati za lijek Entekavir Accord.
The European Medicines Agency concluded that, in accordance with EU requirements, Entecavir Accord has been shown to have comparable quality and to be bioequivalent to Baraclude.
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, za lijek Entekavir Accord dokazana usporediva kakvoća i bioekvivalencija s lijekom Baraclude.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Entecavir Accord have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Entekavir Accord nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
Children weighing 32.6 kg and above can be given the 0.5 mg tablets, while an oral solution of entecavir may be available for children weighing less than 32.6 kg. For further information, see the package leaflet.
Djeci tjelesne težine 32,6 kg i veće mogu se davati tablete od 0,5 mg, a za djecu tjelesne težine manje od 32,6 kg može biti dostupna oralna otopina entekavira.