FrancophonIA/ELRC3.0 huggingface dataset:
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration and marketing authorisation holders in the member states
Croatian: Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene i nositelja odobrenja u državama članicama
English: GES GENÉRICOS ESPAÑOLES LABORATORIO, S.A.
Croatian: Španjolska GES GENÉRICOS ESPAÑOLES LABORATORIO, S.A.
English: Cólquide, 6 - Portal 2, 1º-Oficina F
Croatian: Cólquide, 6 - Portal 2,
English: Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A. 2, A. Fleminga Str.
Croatian: Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A. 2, A.
English: Slovak Republic sanofi-aventis Slovakia s.r.o.
Croatian: Republika Slovačka sanofi-aventis Slovakia s.r.o. Einsteinova 24
English: Luxembourg Profile Pharma Limited Chichester Business Park City Fields Way
Croatian: Luksemburg Profile Pharma Limited Chichester Business Park City Fields Way
English: Sanofi-Aventis France 1-13 boulevard R. Rolland 75014 Paris
Croatian: Sanofi-Aventis France 1-13 boulevard R.
English: Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektionsoder Infusionslösung powder for solution for injection/infusion
Croatian: Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektionsoder Infusionslösung
English: COLIMYCINE 1.000.000 U.I., poudre et solvant pour solution injectable powder and solvent for solution for injection
Croatian: COLIMYCINE 1.000.000 U.I., poudre et solvant pour solution injectable
English: S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1 707410 Iaşi România
Croatian: Rumunjska S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1
English: Colixin 1 milijun IU prašak za otopinu za injekciju powder for solution for injection
Croatian: Colixin 1 milijun IU prašak za otopinu za injekciju
English: COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur powder and solvent for nebuliser solution
Croatian: COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur
English: Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador powder for solution for injection, powder for nebuliser solution
Croatian: Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador
English: Colistimethate sodium 1 million international units powder for solution for injection or infusion powder for solution for injection/infusion
Croatian: Colistimethate sodium 1 million international units powder for solution for injection or infusion
English: Forest Pharma B.V. Newtonlaan 115
Croatian: Forest Pharma B.V.
English: Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador powder for solution for injection, powder for nebuliser solution
Croatian: Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador
English: Pulver zur Herstellung einer Lösung für einer Infusionslösung powder for solution for infusion
Croatian: Pulver zur Herstellung einer Lösung für einer Infusionslösung
English: powder for solution for injection/infusion/ inhalation
Croatian: Powder for solution for injection, infusion or inhalation
English: Colomycin Injection 2 million international units powder for soln for inj, infusion or inhalation powder for solution for injection
Croatian: Colomycin Injection 2 million international units powder for soln for inj, infusion or inhalation
English: Pulver zur Herstellung einer Injektions-/Infusionslösung powder for solution for injection/infusion
Croatian: Pulver zur Herstellung einer Injektions-/Infusionslösung
English: Belgium Forest Laboratories UK Ltd. Riverbridge House
Croatian: Forest Laboratories UK Ltd.
English: Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation powder for solution for injection/infusion/ inhalation
Croatian: Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation
English: Crossways Business Park Dartford
Croatian: Riverbridge House Anchor Boulevard Crossways Business Park Dartford
English: Colomycin Injection 1 million international units powder for soln for inj, infusion or inhalation powder for solution for injection, infusion or inhalation intramuscular use, intravenous use, inhalation use
Croatian: Colomycin Injection 1 million international units powder for soln for inj, infusion or inhalation
English: Colistimethatnatrium "Xellia" 1000000 I.U.
Croatian: Colistimethatnatrium "Xellia" 1000000 IU prašak za otopinu za injekciju/infuziju
English: Promixin 1 million international units (IU) powder for solution for infusion powder for solution for injection intramuscular use, intravenous use
Croatian: Promixin 1 million international units (IU) powder for solution for infusion
English: It is transmitted by mosquitoes and is most common in Asia, particularly in rural areas.
Croatian: Prenosi se komarcima i najčešći je u Aziji, naročito u seoskim područjima.
English: The antibodies will help to protect against the disease.
Croatian: Protutijela će pomoći pri zaštiti od bolesti.
English: Long-term antibody levels were similar with both schedules.
Croatian: Dugoročne razine protutijela bile su slične pri oba rasporeda cijepljenja.
English: • The third main study involved 1,869 children aged between 2 months and 18 years.
Croatian: • U trećem glavnom ispitivanju sudjelovalo je 1 869 djece u dobi od 2 mjeseca do 18 godina.
English: This overview was last updated in 01-2019.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 01. 2019.
English: Further information on Ixiaro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ixiaro.
Croatian: Više informacija o cjepivu Ixiaro nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Ixiaro.
English: This means that the virus is fixed onto aluminium compounds, to stimulate a better response.
Croatian: To znači da je virus vezan na aluminijske spojeve radi poticanja boljeg odgovora.
English: Vaccination must be postponed in people with recent severe fever.
Croatian: Cijepljenje se mora odgoditi u osoba koje su nedavno imale jaku vrućicu.
English: The second dose should be given at least one week before potential exposure to the virus.
Croatian: Drugu dozu treba primijeniti najmanje tjedan dan prije potencijalnoga izlaganja virusu.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend against a disease.
Croatian: Cjepiva djeluju „učeći” imunosni sustav (prirodnu obranu tijela) kako se obraniti od bolesti.
English: Japanese encephalitis can be fatal or lead to long-term disability.
Croatian: Japanski encefalitis može biti smrtonosan ili uzrokovati dugotrajni invaliditet.
English: They also showed that a booster dose might be needed to maintain high levels of protection, which may be necessary for people at high risk of exposure to the virus.
Croatian: Njima je isto tako utvrđeno da bi za održavanje visoke doze zaštite mogla biti potrebna doza docjepljivanja, što bi moglo biti potrebno u osoba u kojih postoji visok rizik od izloženosti virusu.
English: When a person is given the vaccine, the immune system identifies the inactivated virus as ‘foreign' and makes antibodies against it.
Croatian: Kada osoba primi cjepivo, imunosni sustav identificira inaktivirani virus kao „strano tijelo” i proizvodi protutijela protiv njega.
English: In adults, the second dose can be given up to 11 months after the first.
Croatian: U odraslih osoba druga doza može se dati do 11 mjeseci nakon prve.
English: Ixiaro received a marketing authorisation valid throughout the EU on 31 March 2009.
Croatian: Cjepivo Ixiaro dobilo je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 31. ožujka 2009.
English: Side effects reported with Ixiaro are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za cjepivo Ixiaro pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other information about Ixiaro
Croatian: Ostale informacije o lijeku Ixiaro
English: In future, the immune system will be able to produce antibodies quickly and in large numbers when it is exposed to Japanese encephalitis virus again.
Croatian: U budućnosti imunosni sustav moći će brzo proizvesti velik broj protutijela kad bude ponovno izložen virusu japanskog encefalitisa.
English: What measures are being taken to ensure the safe and effective use of Ixiaro?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ixiaro?
English: Before vaccination, most of the people in the study had no protective levels of antibodies against the virus.
Croatian: Prije cijepljenja većina osoba obuhvaćenih ispitivanjem nije imala zaštitnu razinu protutijela protiv virusa.
English: The virus in Ixiaro is grown in mammal cells (‘Vero cells') under laboratory conditions.
Croatian: Virus u cjepivu Ixiaro uzgojen je u stanicama sisavaca („vero stanicama”) u laboratorijskim uvjetima.
English: Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))
Croatian: Ixiaro (cjepivo protiv japanskog encefalitisa (inaktivirano, adsorbirano))
English: The Agency noted that the production of the only other vaccine for protection against Japanese encephalitis that was in use outside Asia had been discontinued.
Croatian: Agencija je napomenula da je obustavljena proizvodnja jedinog drugog cjepiva za zaštitu od virusa japanskog encefalitisa koje se primjenjivalo izvan Azije.
English: It is recommended that individuals who receive the first dose of Ixiaro should receive both doses.
Croatian: Preporučuje se da osobe koje prime prvu dozu cjepiva Ixiaro prime obje doze.
English: A booster dose should also be considered for adults aged above 65 years before any further exposure to the Japanese encephalitis virus.
Croatian: Dozu docjepljivanja treba razmotriti i u odraslih osoba starijih od 65 godina prije svakog sljedećeg izlaganja virusu japanskog encefalitisa.
English: Ixiaro is given by injection into a muscle, preferably into the shoulder muscle, or into the thigh muscle in young children.
Croatian: Ixiaro se primjenjuje injekcijom u mišić, po mogućnosti u rameni mišić, a u male djece u bedreni mišić.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ixiaro have 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 cjepiva Ixiaro nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: What is Ixiaro and what is it used for?
Croatian: Što je Ixiaro i za što se primjenjuje?
English: Anyone who has an allergic reaction after the first dose of Ixiaro should not receive the second dose.
Croatian: Osobe koje imaju alergijsku reakciju nakon prve doze cjepiva Ixiaro ne smiju primiti drugu dozu.
English: Ixiaro must not be used in people who are hypersensitive (allergic) to any residual substances in the vaccine such as protamine sulphate.
Croatian: Ixiaro se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na bilo koju preostalu tvar u cjepivu poput protamin sulfata.
English: The 7-day accelerated vaccination course did not produce lower protection than the standard 4-week vaccination course.
Croatian: Ubrzanim rasporedom cijepljenja u razmaku od sedam dana nije postignuta niža razina zaštite nego uobičajenim cijepljenjem u razmaku od četiri tjedna.
English: Ixiaro contains small amounts of the virus that causes Japanese encephalitis, which has been inactivated (killed) so that it cannot cause the disease.
Croatian: Ixiaro sadržava male količine virusa koji uzrokuje japanski encefalitis, a koji je inaktiviran (ubijen) tako da ne može uzrokovati bolest.
English: Vaccination with Ixiaro should be considered for people who are at risk of exposure to the Japanese encephalitis virus through travel or work.
Croatian: Primjenu cjepiva Ixiaro treba razmotriti u osoba u kojih postoji rizik od izloženosti virusu japanskog encefalitisa tijekom putovanja ili posla.
English: • The second main study in 660 adults compared a rapid vaccination course (2 doses given 7 days apart) with the standard vaccination course (2 doses given 4 weeks apart).
Croatian: • U drugom glavnom ispitivanju, kojim je bilo obuhvaćeno 660 osoba, cijepljenje prema brzom rasporedu (dvije doze dane u razmaku od sedam dana) uspoređeno je s uobičajenim rasporedom cijepljenja (dvije doze dane u razmaku od četiri tjedna).
English: Ixiaro can only be obtained with a prescription.
Croatian: Ixiaro se izdaje samo na liječnički recept.
English: An overview of Ixiaro and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ixiaro i zašto je odobren u EU-u
English: Adults from 18 to 65 years can also receive a rapid vaccination course, where the second dose is given seven days after the first dose.
Croatian: Odrasle osobe u dobi od 18 do 65 godina mogu primiti i cijepljenje prema brzom rasporedu, pri čemu se druga doza daje sedam dana nakon prve.
English: On average, the levels of antibodies were over 2 times higher in the people receiving Ixiaro than in those receiving the comparator vaccine.
Croatian: Razine protutijela bile su prosječno više od 2 puta veće u osoba koje su primile cjepivo Ixiaro nego u onih koje su primile usporedno cjepivo.
English: In adults, including those aged above 65 years, and children aged 3 years and older, a full dose of Ixiaro (0.5 ml) should be given, and an additional 0.5 ml dose should be given four weeks later.
Croatian: Odraslim osobama, uključujući i one starije od 65 godina, te djeci u dobi od tri godine ili starijoj, treba dati punu dozu cjepiva Ixiaro (0,5 ml) te dodatnu dozu od 0,5 ml četiri tjedna kasnije.
English: Children and adolescents may also receive a booster dose one to two years after the initial vaccination.
Croatian: Djeca i adolescenti mogu također primiti dozu docjepljivanja jednu do dvije godine nakon prvog cijepljenja.
English: The European Medicines Agency decided that Ixiaro's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od cjepiva Ixiaro nadmašuju s njim povezane rizike te da ono može biti odobreno za primjenu u Europskoj uniji.
English: 99% to 100% of children who received both doses of Ixiaro had developed protective levels of antibodies against the Japanese encephalitis virus 4 weeks after the final injection.
Croatian: U 99 % do 100 % djece koja su primila obje doze cjepiva Ixiaro razvila se zaštitna razina protutijela protiv virusa japanskog encefalitisa četiri tjedna nakon posljednje injekcije.
English: For more information about using Ixiaro, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni cjepiva Ixiaro pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: In addition, the company presented the results of studies looking at the level of protection in adults and in children for up to 3 years after vaccination with Ixiaro, and at the response to booster doses.
Croatian: Osim toga, tvrtka je predstavila rezultate ispitivanja u kojima se proučavala razina zaštite u odraslih osoba i u djece tijekom razdoblja od najviše tri godine nakon primjene cjepiva Ixiaro te odgovor na doze docjepljivanja.
English: • The first study involved 867 healthy adults and compared Ixiaro with another vaccine for Japanese encephalitis containing viruses grown in mouse brains.
Croatian: • U prvom ispitivanju, kojim je bilo obuhvaćeno 867 zdravih odraslih osoba, cjepivo Ixiaro uspoređeno je s drugim cjepivom protiv japanskog encefalitisa koje je sadržavalo viruse uzgojene u mozgovima miševa.
English: Ixiaro is a vaccine that helps protect adults and children aged 2 months and older against Japanese encephalitis, a disease that causes inflammation of the brain.
Croatian: Ixiaro je cjepivo koje pomaže zaštititi odrasle osobe i djecu stariju od dva mjeseca od japanskog encefalitisa, bolesti koja uzrokuje upalu mozga.
English: The most common side effects with Ixiaro in adults (which may affect more than 1 in 10 people) are headache, myalgia (muscle pain), pain and tenderness at the injection site and tiredness.
Croatian: Prilikom primjene cjepiva Ixiaro najčešće nuspojave u odraslih osoba (koje se mogu javiti u više od 1 na 10 osoba) su glavobolja, mijalgija (bol u mišićima), bol i osjetljivost na dodir na mjestu primjene injekcije te umor.
English: What are the risks associated with Ixiaro?
Croatian: Koji su rizici povezani s lijekom Ixiaro?
English: Adults from 18-65 years who are likely to be exposed to the Japanese encephalitis virus again or who are at continuous risk of the disease should receive a booster dose of Ixiaro one to two years later and a second booster dose 10 years after the first booster.
Croatian: Odrasle osobe u dobi od 18 do 65 godina u kojih postoji vjerojatnost za ponovnu izloženost virusu japanskog encefalitisa ili koje su stalno izložene riziku od obolijevanja trebaju primiti dozu docjepljivanja cjepivom Ixiaro godinu do dvije nakon toga, te drugu dozu docjepljivanja 10 godina nakon prvog docjepljivanja.
English: In children aged between 2 months and 3 years, half the adult dose of Ixiaro (0.25 ml) should be given, and an additional 0.25 ml dose should be given four weeks later.
Croatian: Djeci u dobi od dva mjeseca do tri godine treba dati polovicu doze cjepiva Ixiaro predviđene za odrasle (0,25 ml) te dodatnu dozu od 0,25 ml četiri tjedna kasnije.
English: Why is Ixiaro authorised in the EU?
Croatian: Zašto je lijek Ixiaro odobren u EU-u?
English: Ixiaro (given as 2 doses 4 weeks apart) was as effective as the comparator vaccine at triggering the production of antibodies against the Japanese encephalitis virus.
Croatian: Cjepivo Ixiaro (primijenjeno u dvije doze u razmaku od četiri tjedana) bilo je jednako učinkovito kao i usporedno cjepivo pri poticanju proizvodnje protutijela protiv virusa japanskog encefalitisa.
English: As for all medicines, data on the use of Ixiaro are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni cjepiva Ixiaro kontinuirano se prate.
English: Four weeks after the final injection, 96% of these people who received both doses of Ixiaro had developed protective levels of antibodies (352 out of 365).
Croatian: Četiri tjedna nakon posljednje injekcije 96 % (352 od 365) osoba koje su primile obje doze cjepiva Ixiaro razvilo je zaštitnu razinu protutijela, u usporedbi s 94 % (347 od 370) osoba koje su primile usporedno cjepivo.
English: What benefit of Ixiaro have been shown in studies?
Croatian: Koje su koristi od lijeka Ixiaro utvrđene u ispitivanjima?
English: How does Ixiaro work?
Croatian: Kako djeluje Ixiaro?
English: These additional studies showed that protection against Japanese encephalitis virus lasted for at least 2 to 3 years in most people vaccinated with Ixiaro.
Croatian: Tim je dodatnim ispitivanjima utvrđeno da u većine osoba cijepljenih cjepivom Ixiaro zaštita od virusa japanskog encefalitisa traje najmanje dvije do tri godine.
English: In children, fever, diarrhoea, influenza-like illness, irritability, and reactions at the injection site (such as redness,
Croatian: U djece najčešće su nuspojave (koje se mogu javiti u više od 1 na 10 djece) vrućica, proljev, bolest slična gripi, nadražljivost i reakcije na mjestu primjene injekcije (crvenilo, bol i osjetljivost na dodir).
English: How is Ixiaro used?
Croatian: Kako se Ixiaro primjenjuje?
English: Ixiaro has been shown to trigger the production of antibodies against the Japanese encephalitis virus in 3 main studies:
Croatian: U trima glavnim ispitivanjima utvrđeno je da Ixiaro potiče proizvodnju protutijela protiv virusa japanskog encefalitisa.
English: Ixiaro can be injected under the skin in people who have a bleeding disorder such as low blood platelet counts or haemophilia.
Croatian: Osobama koje imaju poremećaj krvarenja kao što je mali broj trombocita ili hemofilija cjepivo Ixiaro se može ubrizgati pod kožu.
English: For the full list of side effects of Ixiaro, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih prilikom primjene cjepiva Ixiaro potražite u uputi o lijeku.
English: What is closantel?
Croatian: Što je klozantel?
English: 20 May 2019
Croatian: 20. svibnja 2019.
English: The European Commission issued a decision on 20 May 2019.
Croatian: Europska komisija donijela je odluku 20. svibnja 2019.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/126)
Croatian: Ishod arbitražnog postupka u skladu s člankom 35. Direktive 2001/82/EZ (EMEA/V/A/126)
English: In addition, cattle may also be treated topically on their skin.
Croatian: Osim toga, goveda se također mogu liječiti lokalno, primjenom lijeka na koži.
English: Why were solutions for injection containing 50 mg closantel per ml (as a single active substance) reviewed?
Croatian: Zašto su otopine za injekciju koje sadržavaju 50 mg klozantela po ml (kao jedinu djelatnu tvar) ocijenjene?
English: Closantel is intended for use in cattle and sheep for the treatment and control of adult and immature flukes, nematodes and larval stages of some arthropods and is administered subcutaneously by injection or as an oral solution.
Croatian: Klozantel je namijenjen za primjenu u goveda i ovaca za liječenje i kontrolu odraslih i nezrelih metilja, nematoda i stadija ličinki određenih člankonožaca i primjenjuje se supkutanom injekcijom ili kao oralna otopina.
English: Consequently, on 5 February 2018, the United Kingdom initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Croatian: Ujedinjena Kraljevina pokrenula je postupak u skladu s člankom 35. Direktive 2001/82/EZ za navedene veterinarsko-medicinske proizvode.
English: Withdrawal period refers to the minimum period of time from administering the last dose of veterinary medicinal product and the production of meat or other animal-derived products for food.
Croatian: Razdoblje karencije odnosi se na najkraće vremensko razdoblje od primjene posljednje doze veterinarsko-medicinskog proizvoda do proizvodnje mesa ili drugog proizvoda životinjskog podrijetla za hranu.
English: The United Kingdom noted that, for veterinary medicinal products containing closantel presented as solutions for injection, there are different approved withdrawal periods for sheep across the European Union e.g. sheep meat and offal, from 28 days to 107 days.
Croatian: Ujedinjena Kraljevina primijetila je da za veterinarsko-medicinske proizvode koji sadržavaju klozantel u obliku otopine za injekciju postoje različita odobrena razdoblja karencije za ovce diljem Europske unije, npr. za meso i iznutrice ovaca, od 28 dana do 107 dana.
English: On 21 February 2019, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat and offal) for sheep for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection.
Croatian: Europska agencija za lijekove (Agencija) dovršila je 21. veljače 2019. ocjenjivanje sigurnosti potrošača u pogledu razdoblja karencije za ovce (meso i iznutrice) kod veterinarsko-medicinskih proizvoda koji sadržavaju 50 mg klozantela po ml (kao jedinu djelatnu tvar) u obliku otopine za injekciju.
English: The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for meat and offal derived from treated sheep.
Croatian: Od CVMP-a je zatraženo da pregleda sve dostupne podatke o izlučivanju rezidua i preporuči razdoblja karencije za meso i iznutrice dobivene od liječenih ovaca.