FrancophonIA/ELRC3.0 huggingface dataset:
English: Astellas Pharma Co. Ltd. Tel: + 353 (0)1 4671555
Croatian: Astellas Pharma Ges.m.b.H. Tel: + 43 (0)1 8772668
English: Астелас Фарма ЕООД Teл.
Croatian: Magyarország Astellas Pharma Kft.
English: This improves the ability to produce antibodies.
Croatian: To poboljšava mogućnost proizvodnje antitijela.
English: This helps to protect against the diseases that these bacteria and viruses cause.
Croatian: To pomaže u zaštiti protiv bolesti koje te bakterije i virusi uzrokuju.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend itself against diseases.
Croatian: Cjepiva djeluju „učeći” imunosni sustav (prirodnu obranu tijela) kako da se brani od bolesti.
English: It is used in babies and toddlers aged from six weeks to protect against the following infectious diseases:
Croatian: Primjenjuje se u dojenčadi i male djece u dobi od šest tjedana radi zaštite od sljedećih zaraznih bolesti:
English: The full EPAR and risk management plan summary for Vaxelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Vaxelis nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: With regard to safety, the CHMP considered that overall its safety profile is similar to other vaccines.
Croatian: U pogledu sigurnosti, CHMP je smatrao da je, ukupno gledajući, sigurnosni profil lijeka sličan drugim cjepivima.
English: The vaccine is ‘adsorbed' on aluminium compounds.
Croatian: Cjepivo je „adsorbirano” na aluminijske spojeve.
English: • hepatitis B (a viral liver infection);
Croatian: • hepatitisa B (virusne infekcije jetre);
English: This is a summary of the European public assessment report (EPAR) for Vaxelis.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Vaxelis.
English: This means that some of the active substances are fixed onto minute particles of aluminium compounds.
Croatian: To znači da su neke od djelatnih tvari pričvršćene na sitne čestice aluminijskih spojeva.
English: These antibody levels have been previously shown to protect against these diseases.
Croatian: Prethodno se pokazalo da te razine antitijela štite protiv tih bolesti.
English: Vaccination with Vaxelis should be carried out according to official recommendations.
Croatian: Cijepljenje lijekom Vaxelis treba obavljati u skladu sa službenim preporukama.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vaxelis'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 od lijeka Vaxelis nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: • diphtheria (a highly contagious disease that affects the throat and skin, and can cause damage to the heart and other organs);
Croatian: • difterije (vrlo zarazne bolesti koja pogađa grlo i kožu i koja može uzrokovati oštećenje srca i drugih organa);
English: Both studies showed that Vaxelis produces satisfactory levels of antibodies to protect against all of these six diseases in between 90 and 100% of children who completed the course of vaccination with Vaxelis.
Croatian: Oba su ispitivanja pokazala da Vaxelis proizvodi zadovoljavajuće razine antitijela za zaštitu od svih tih šest bolesti u između 90 i 100 % djece koja su završila ciklus cijepljenja Vaxelisom.
English: It must not be used in children who have an uncontrolled or severe illness affecting the brain or nervous system, such as uncontrolled epilepsy (fits), unless the condition has stabilised with treatment and the benefit of vaccination clearly outweighs the risk.
Croatian: Ne smije se primjenjivati u djece koja imaju nekontroliranu ili tešku bolest koja utječe na mozak ili živčani sustav kao što je nekontrolirana epilepsija (napadaji), osim u slučaju kada je stanje stabilizirano liječenjem i kada koristi cijepljenja jasno nadmašuju rizik.
English: A booster dose should be given at least six months after the last of these initial doses.
Croatian: Doza docjepljivanja daje se najmanje šest mjeseci nakon davanja posljednje od početnih doza.
English: What measures are being taken to ensure the safe and effective use of Vaxelis?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vaxelis?
English: It can only be obtained with a prescription.
Croatian: Izdaje se samo na liječnički recept.
English: Other information about Vaxelis
Croatian: Ostale informacije o lijeku Vaxelis
English: Vaxelis has been studied in two main studies involving more than 2,500 infants and toddlers over six weeks of age who were given either two or three doses of the vaccine during their first six months of life.
Croatian: Vaxelis je ispitivan u dvjema glavnim studijama na više od 2 500 dojenčadi i male djece starije od šest tjedana kojima su dane dvije ili tri doze cjepiva u prvih šest mjeseci njihova života.
English: It is not intended to provide practical advice on how to use Vaxelis.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Vaxelis.
English: The recommended initial vaccination schedule is either two or three doses, given at least one month apart to children aged over six weeks.
Croatian: Preporučeni početni raspored cijepljenja jest dvije ili tri doze koje se daju u razmaku od najmanje jednog mjeseca djeci starijoj od šest tjedana.
English: • tetanus (lockjaw, usually caused by infection of a wound);
Croatian: • tetanusa (obično uzrokovanog infekcijom rane);
English: When a child is given the vaccine, the immune system recognises the materials from the bacteria and viruses as foreign and makes antibodies against them.
Croatian: Kada dijete primi cjepivo, imunosni sustav prepoznaje materijale iz bakterija i virusa kao strana tijela” i proizvodi antitijela protiv njih.
English: Vaxelis must not be used in children who have ever had an allergic reaction to Vaxelis or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin).
Croatian: Vaxelis se ne smije primjenjivati u djece koja su imala alergijske reakcije na Vaxelis ili neko cjepivo koje sadrži iste sastavnice, uključujući tvari koje se koriste tijekom proizvodnje cjepiva i koje se mogu naći u vrlo niskim razinama (kao što su antibiotici neomicin i streptomicin).
English: It must not be used in children who have ever had encephalopathy (a brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components.
Croatian: Ne smije se primjenjivati u djece koja su imala encefalopatiju (bolest mozga) nepoznatog uzroka u roku od sedam dana od primanja cjepiva koje sadrži sastavnice hripavca.
English: Vaxelis contains small amounts of materials derived from the viruses and bacteria it protects against.
Croatian: Vaxelis sadrži male količine materijala koji potječu iz virusa i bakterija protiv kojih taj lijek štiti.
English: Vaxelis is given by injection into a muscle, normally in the upper thigh or the shoulder.
Croatian: Vaxelis se daje injekcijom u mišić, obično u natkoljenicu ili rame.
English: What is Vaxelis and what is it used for?
Croatian: Što je Vaxelis i za što se koristi?
English: • poliomyelitis (polio, a disease that affects the nerves and can lead to muscle weakness or paralysis);
Croatian: • poliomijelitisa (dječje paralize, bolesti koja pogađa živce i koja može dovesti do oslabljenja mišića ili paralize);
English: The effects of Vaxelis were compared with those of another vaccine, Infanrix hexa, designed to protect against the same six diseases as Vaxelis.
Croatian: Učinci lijeka Vaxelis uspoređivani su s učincima drugog cjepiva, Infanrix hexa, koje je namijenjeno zaštiti od istih šest bolesti kao i Vaxelis.
English: They then received a booster dose shortly after their first birthday.
Croatian: Nakon prvog rođendana ubrzo su primili dozu docjepljivanja.
English: Why is Vaxelis approved?
Croatian: Zašto je Vaxelis odobren?
English: The most common side effects with Vaxelis include pain, swelling and redness at the site of injection, irritability, crying, sleepiness, fever, reduced appetite and vomiting.
Croatian: Najčešće nuspojave lijeka Vaxelis uključuju bol, oticanje i crvenilo na mjestu injekcije, razdražljivost, plač, pospanost, groznicu, smanjeni apetit i povraćanje.
English: • invasive diseases (such as pneumonia and meningitis) caused by H. influenzae type-b bacteria
Croatian: • invazivnih bolesti (poput upale pluća i meningitisa) uzrokovanih bakterijom H. influenzae tipa b (Hib).
English: A risk management plan has been developed to ensure that Vaxelis is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Vaxelis.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vaxelis, 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 Vaxelis nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Vaxelis is available in pre-filled syringes as a suspension for injection.
Croatian: Vaxelis je dostupan u unaprijed napunjenim štrcaljkama kao otopina za injekciju.
English: For more information about treatment with Vaxelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Vaxelis pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: What are the risks associated with Vaxelis?
Croatian: Koji su rizici povezani s lijekom Vaxelis?
English: In these studies, children also received other vaccines according to local vaccination schedules to protect against other childhood diseases such as rotavirus gastroenteritis, measles, mumps, rubella and varicella.
Croatian: Djeca su u tim ispitivanjima također primila druga cjepiva sukladno lokalnim rasporedima cijepljenja protiv drugih dječjih bolesti kao što su rotavirus gastroenteritis, ospice, zaušnjaci, rubeola i vodene kozice.
English: Vaxelis or an appropriate combination of other vaccines can be used for the booster dose.
Croatian: Za dozu docjepljivanja može se koristiti Vaxelis ili odgovarajuća kombinacija drugih cjepiva.
English: The main measure of effectiveness was the production of antibody levels known to be protective against diphtheria, tetanus, poliomyelitis, hepatitis B and H. influenzae type b infections and expected to protect against pertussis.
Croatian: Glavna mjera učinkovitosti bila je razina proizvodnje antitijela za koju se zna da štiti od difterije, tetanusa, poliomijelitisa, hepatitisa B i infekcija bakterijom H. influenzae tipa b i za koju se očekuje da štiti od hripavca.
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
Croatian: Cjepivo protiv difterije, tetanusa, hripavca (nestanično, komponentno), hepatitisa B (rDNK), poliomijelitisa (inaktivirano) i Haemophilus influenzae tipa b konjugirano (adsorbirano)
English: What benefits of Vaxelis have been shown in studies?
Croatian: Koje su koristi od lijeka Vaxelis utvrđene u ispitivanjima?
English: How does Vaxelis work?
Croatian: Kako djeluje Vaxelis?
English: For practical information about using Vaxelis, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Vaxelis pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: The Committee considered that Vaxelis has been shown to produce satisfactory antibody levels against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses and Hib.
Croatian: Odbor je smatrao da se pokazalo da Vaxelis proizvodi zadovoljavajuće razine antitijela protiv difterije, tetanusa, hripavca, virusa hepatitisa B, poliovirusa i bakterije Hib.
English: • pertussis (whooping cough);
Croatian: • hripavca (velikog kašlja);
English: Vaxelis is a vaccine.
Croatian: Vaxelis je cjepivo.
English: Vaxelis is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type-b bacteria, the hepatitis B virus, and inactivated polioviruses.
Croatian: Vaxelis je cjepivo koje sadrži djelatne tvari koje potječu iz bakterija difterije, tetanusa, hripavca i bakterije Haemophilus influenzae tipa b, virusa hepatitisa B i inaktiviranih poliovirusa.
English: The immune system will then be able to produce antibodies quickly when the person is naturally exposed to the bacteria or viruses.
Croatian: Kada osoba bude prirodno izložena bakterijama ili virusima, imunosni sustav bit će u mogućnosti brzo proizvesti antitijela.
English: How is Vaxelis used?
Croatian: Kako se Vaxelis koristi?
English: For the full list of all side effects reported with Vaxelis, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vaxelis potražite u uputi o lijeku.
English: The reasons for this are not clear.
Croatian: Razlozi za to nisu poznati.
English: This summary was last updated in September 2016.
Croatian: Ovaj sažetak je posljednji put ažuriran u rujnu 2016.
English: Hands should be washed after use.
Croatian: Nakon uporabe potrebno je oprati ruke.
English: If symptoms persist, get worse or come back, treatment should be changed to another antibiotic.
Croatian: Ako su simptomi i dalje prisutni, ako se pogoršaju ili vrate, liječenje treba nastaviti drugim antibiotikom.
English: It is recommended that animals are treated in the early stages of respiratory disease and that their response is evaluated within 48 hours.
Croatian: Preporučuje se liječenje životinja u ranoj fazi respiratorne bolesti te procjena njihova odgovora unutar 48 sati.
English: The full EPAR for Draxxin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/ European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Draxxin nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/ European public assessment reports.
English: The main measure of effectiveness was the change in symptoms, including body temperature, breathing and recovery over a period of between two weeks and two months.
Croatian: Glavno mjerilo djelotvornosti bila je promjena simptoma, uključujući tjelesnu temperaturu, disanje i oporavak tijekom razdoblja od dva tjedna do dva mjeseca.
English: The main measure of effectiveness was the proportion of cattle whose disease was cured after three weeks.
Croatian: Glavno mjerilo djelotvornosti bio je broj goveda kod kojih je bolest izliječena nakon tri tjedna.
English: If Draxxin accidentally gets into the eyes, they should be flushed immediately with clean water.
Croatian: Ako Draxxin slučajno dođe u kontakt s očima, treba ih odmah isprati čistom vodom.
English: If accidental skin exposure occurs, the skin should be washed immediately with soap and water.
Croatian: U slučaju nehotičnog izlaganja kože, kožu treba odmah oprati sapunom i vodom.
English: Draxxin can cause eye irritation.
Croatian: Draxxin može uzrokovati iritaciju oka.
English: However, some bacteria can develop resistance against tulathromycin, which will reduce its effectiveness.
Croatian: Međutim, neke bakterije mogu razviti otpornost na tulatromicin, što umanjuje njegovu djelotvornost.
English: The main measure of effectiveness was the change in symptoms over 10 days.
Croatian: Glavno mjerilo djelotvornosti bilo je promjena simptoma tijekom 10 dana.
English: For cattle the meat withdrawal period is 22 days, for pigs it is 13 days and for sheep it is 16 days.
Croatian: Kod goveda karencija za meso iznosi 22 dana, kod svinja 13 dana, a kod ovaca 16 dana.
English: This means that the antibiotic may no longer work on bacteria infecting either animals or humans.
Croatian: To znači da postoji mogućnost da antibiotik više ne djeluje na bakterije koje pogađaju životinje ili ljude.
English: Draxxin tulathromycin
Croatian: Draxxin tulatromicin
English: The main measure of effectiveness was the proportion of pigs that completed the full three or six weeks of each study without needing to be removed from the study because of SRD.
Croatian: Glavno mjerilo djelotvornosti bio je udio svinja koje su prošle punih tri ili šest tjedana svakog ispitivanja bez potrebe za uklanjanjem iz ispitivanja zbog SRD-a.
English: It should also not be used at the same time as other macrolide antibiotics or lincosamides (another type of antibiotic medicine).
Croatian: Također se ne smije koristiti istovremeno s drugim makrolidnim antibioticima ili linkozamidima (druga vrsta antibiotika).
English: Antibiotic resistance is the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth.
Croatian: Otpornost na antibiotik predstavlja sposobnost bakterija da rastu u prisutnosti antibiotika koji bi ih inače uništio ili ograničio njihov rast.
English: This has not been seen in pigs and sheep after intramuscular injection.
Croatian: To nije uočeno u svinja niti ovaca nakon injekcije u mišić.
English: Draxxin is available as a solution for injection (25 mg/ml and 100 mg/ml).
Croatian: Draxxin je dostupan kao otopina za injekciju (25 mg/ml i 100 mg/ml).
English: This is a summary of the European Public Assessment Report (EPAR) for Draxxin.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o VMP-u Draxxin.
English: What is Draxxin and what is it used for?
Croatian: Što je Draxxin i za što se koristi?
English: In the treatment studies, the cattle were infected with BRD-causing bacteria, but the cattle in the prevention studies had no symptoms of the disease.
Croatian: U terapijskim ispitivanjima goveda su bila zaražena bakterijama koje uzrokuju BRD, ali u ispitivanjima prevencije goveda nisu imala simptome bolesti.
English: Why is Draxxin approved?
Croatian: Zašto je Draxxin odobren?
English: Draxxin should not be used in animals that are hypersensitive (allergic) to macrolide antibiotics.
Croatian: Draxxin se ne smije koristiti u životinja koje su preosjetljive (alergične) na makrolidne antibiotike.
English: Looking at the studies taken together, it was more effective than placebo.
Croatian: Promatrajući ukupno rezultate ispitivanja, bio je djelotvorniji od placeba.
English: Two weeks after treatment 84% of Draxxin-treated sheep were successfully treated compared to 82% of tilmicosin-treated sheep.
Croatian: Dva tjedna nakon terapije 84 % ovaca koje su primile VMP Draxxin bilo je uspješno izliječeno, u usporedbi s 82 % ovaca koje su primile tilmikozin.
English: Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica.
Croatian: Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis i Bordetella bronchiseptica;
English: This prevents the bacteria being able to make vital proteins and stops them growing and multiplying.
Croatian: Time se bakterije onemogućuju u stvaranju vitalnih proteina, čime se zaustavlja njihov rast i razmnožavanje.
English: Other information about Draxxin:
Croatian: Ostale informacije o VMP-u Draxxin:
English: The European Commission granted a marketing authorisation valid throughout the EU for Draxxin on 23 July 2003.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Draxxin na snazi u Europskoj uniji od 23. srpnja 2003.
English: The medicine should only be used for metaphylaxis in cattle and pigs once the presence of the disease in the herd has been established, and if animals are expected to develop the disease within two to three days.
Croatian: VMP se smije koristiti metafilaktički u goveda i svinja tek kad je utvrđena prisutnost bolesti u stadu te ako se očekuje da će se bolest razviti u životinja u sljedeća dva do tri dana.
English: In sheep, Draxxin is injected into the neck muscle.
Croatian: U ovaca Draxxin se ubrizgava u vratni mišić.
English: Draxxin is used to treat the following diseases if they are caused by bacteria that are sensitive to tulathromycin:
Croatian: Draxxin se koristi za liječenje sljedećih bolesti ako su uzrokovane bakterijama osjetljivima na tulatromicin:
English: Draxxin may also cause sensitisation (redness, itching and swelling) if it comes into contact with the skin.
Croatian: Draxxin može također uzrokovati senzitizaciju (crvenilo, svrbež i oticanje) ako dođe u dodir s kožom.
English: The most common side effects with Draxxin in sheep (which may affect more than 1 in 10 sheep) are short lived signs of discomfort (head shaking, rubbing the injection site and backing away) lasting only a few minutes.
Croatian: Najčešće nuspojave kod primjene VMP-a Draxxin u ovaca (koje se mogu pojaviti u više od 1 na 10 ovaca) su kratkotrajni znakovi neugode (tresenje glavom, češanje mjesta injekcije i uzmicanje) koji traju samo nekoliko minuta.
English: It works by attaching to the RNA (the molecules that instruct the cell how to make proteins) within the bacterial cells.
Croatian: Djeluje na način da se vezuje na RNK (molekule koje upućuju stanice kako stvarati proteine) unutar stanica bakterija.
English: Draxxin is given as a single injection of 2.5 mg per kilogram bodyweight.
Croatian: Draxxin se daje kao jedna injekcija u dozi od 2,5 mg po kilogramu tjelesne težine.
English: However, the third study found no difference between the effectiveness of Draxxin, oxytetracycline and placebo.
Croatian: Međutim, trećim ispitivanjem nije dokazana razlika u djelotvornosti VMP-a Draxxin, oksitetraciklina i placeba.
English: The main measure of effectiveness was clinical cure rate (no SRD or mild SRD) on day 14.
Croatian: Glavno mjerilo djelotvornosti bila je stopa kliničkog izlječenja (nepostojanje SRD-a ili blagi oblik SRD-a) 14. dana.
English: • swine respiratory disease (SRD) in pigs caused by Actinobacillus pleuropneumoniae,
Croatian: • respiratorne bolesti svinja (SRD) uzrokovane bakterijama Actinobacillus pleuropneumoniae,
English: The 25 mg/ml solution for injection is for pigs only whilst the 100 mg/ml solution for injection is for cattle, pigs and sheep.
Croatian: Otopina za injekciju od 25 mg/ml namijenjena je samo za svinje, dok je otopina za injekciju od 100 mg/ml namijenjena za goveda, svinje i ovce.
English: This means to treat at the same time both diseased animals and those clinically healthy animals in close contact with them, to prevent them from developing clinical signs and to prevent further spread of the disease.
Croatian: To znači istodobno liječenje bolesne stoke i stoke koja je klinički zdrava, ali u bliskom kontaktu s bolesnom stokom, kako bi se spriječio razvoj kliničkih znakova te daljnje širenje bolesti.
English: In case of accidental selfinjection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Croatian: U slučaju nehotičnog samoinjektiranja potrebno je odmah potražiti liječnički savjet te liječniku pokazati uputu o proizvodu ili etiketu.
English: Draxxin was compared with tilmicosin or florfenicol (other antibiotics), and, in the prevention studies also with placebo (a dummy treatment).
Croatian: Draxxin je uspoređen s tilmikozinom ili florfenikolom (drugim antibioticima), a u ispitivanjima prevencije također i s placebom (prividnim liječenjem).
English: For the best results sheep with foot rot should be kept in a dry environment.
Croatian: Kako bi se postigao najbolji mogući rezultat, ovce s truleži papaka treba držati u suhom prostoru.