FrancophonIA/ELRC3.0 huggingface dataset:
English: − to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Croatian: kirschneri serotip Grippotyphosa serovar Grippotyphosa.
English: At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus.
Croatian: Aktivna imunizacija pasa starijih od 6 tjedana: - sprječavanje uginuća i kliničkih znakova bolesti uzrokovanih virusom štenećaka, - sprječavanje uginuća i kliničkih znakova bolesti uzrokovanih psećim adenovirusom tipa 1, - sprječavanje kliničkih znakova i smanjivanje izlučivanja virusa uzrokovanog psećim adenovirusom tipa 2,
English: Further information on Prolia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Prolia nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This overview was last updated in 06-2018.
Croatian: Ovaj sažetak posljednji je put ažuriran u 06. 2018.
English: Prolia is a medicine used to treat the following conditions:
Croatian: Prolia je lijek koji se koristi za liječenje sljedećih stanja:
English: What measures are being taken to ensure the safe and effective use of Prolia?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Prolia?
English: Prolia received a marketing authorisation valid throughout the EU on 26 May 2010.
Croatian: Lijek Prolia dobio je odobrenje za stavljanje u promet koje vrijedi na prostoru EU-a od 26. svibnja 2010.
English: Osteoporosis in women
Croatian: Osteoporoza u žena
English: Other information about Prolia
Croatian: Ostale informacije o lijeku Prolia
English: Side effects reported with Prolia are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Prolia pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Prolia must not be used in people with hypocalcaemia (low blood calcium levels).
Croatian: Lijek Prolia ne smije se primjenjivati u osoba s hipokalcemijom (niskom razinom kalcija u krvi).
English: By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
Croatian: Vezujući se na RANKL i blokirajući ga, denosumab smanjuje stvaranje i djelovanje osteoklasta.
English: Osteoporosis in men
Croatian: Osteoporoza u muškaraca
English: The medicine contains the active substance denosumab.
Croatian: Lijek sadrži djelatnu tvar denosumab.
English: Prolia reduces the risk of fractures in the spine;
Croatian: Prolia smanjuje rizik od fraktura kralježnice;
English: This reduces the loss of bone and maintains bone strength, making fractures less likely to happen.
Croatian: Time se smanjuje gubitak kostiju i pomaže očuvati njihova jačina, što smanjuje vjerojatnost od fraktura.
English: What are the risks associated with Prolia?
Croatian: Koji su rizici povezani s lijekom Prolia?
English: What is Prolia and what is it used for?
Croatian: Što je Prolia i za što se primjenjuje?
English: Why is Prolia authorised in the EU?
Croatian: Zašto je lijek Prolia odobren u EU-u?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prolia have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Prolia također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Croatian: RANKL je uključen u aktivaciju osteoklasta, stanica u tijelu koje su uključene u razgradnju koštanog tkiva.
English: Prolia is available as a solution for injection in prefilled syringes, each containing 60 mg denosumab.
Croatian: Lijek Prolia dostupan je kao otopina za injekciju u napunjenim štrcaljkama, od kojih svaka sadrži 60 mg denosumaba.
English: In addition, after 3 years the risk of new spine fractures was lower in patients who received Prolia.
Croatian: Osim toga, nakon tri godine rizik od novih faktura kralježnice bio je niži u bolesnika koji su primali lijek Prolia.
English: How does Prolia work?
Croatian: Kako djeluje Prolia?
English: An overview of Prolia and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Prolia i zašto je odobren u EU-u
English: Prolia can be given by someone who has been trained in how to give injections appropriately.
Croatian: Lijek Prolia može davati osoba osposobljena za ispravno davanje injekcija.
English: In the second study, the women were receiving treatment for breast cancer and were considered to be at high risk of fracture.
Croatian: U drugom ispitivanju žene su primale terapiju protiv raka dojke i smatralo se da kod njih postoji visok rizik od frakture.
English: As for all medicines, data on the use of Prolia are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Prolia kontinuirano se prate.
English: The active substance in Prolia, denosumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific structure in the body called RANKL.
Croatian: Djelatna tvar u lijeku Prolia, denosumab, monoklonsko je protutijelo (vrsta bjelančevine) dizajnirano za prepoznavanje i vezivanje na određenu strukturu u tijelu naziva RANKL.
English: The company that markets Prolia will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Croatian: Tvrtka koja stavlja lijek Prolia u promet bolesnicima će osigurati karticu s informacijama o riziku od osteonekroze čeljusti i uputom da se obrate svom liječniku ako se kod njih pojave opisani simptomi.
English: The European Medicines Agency decided that Prolia'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 lijeka Prolia nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: • osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones).
Croatian: • osteoporoze (bolesti koja kosti čini lomljivima) u žena u postmenopauzi i u muškaraca kod kojih je prisutan povećani rizik od frakture (loma kostiju).
English: Uncommon or rare cases of cellulitis (inflammation of deep skin tissue), hypocalcaemia (low blood calcium), hypersensitivity (allergy), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and unusual fractures of the thigh bone have been seen in patients taking Prolia.
Croatian: U bolesnika koji uzimaju lijek Prolia zabilježeni su manje česti ili rijetki slučajevi celulitisa (upale dubokog potkožnog tkiva), hipokalcemije (niske razine kalcija u krvi), preosjetljivosti (alergije), osteonekroze čeljusti (oštećenja kosti čeljusti koja mogu prouzročiti bol, rane u ustima ili klimanje zuba) i neuobičajenih fraktura bedrene kosti.
English: Bone loss in adults receiving long-term corticosteroid therapy
Croatian: Gubitak kostiju u odraslih koji primaju dugotrajnu terapiju kortikosteroidima
English: The most common side effects with Prolia (seen in more than 1 patient in 10) are pain in the arms or legs, and bone, joint and muscle pain.
Croatian: Najčešće nuspojave lijeka Prolia (koje se mogu javiti u više od 1 na 10 osoba) su bol u rukama, nogama, kostima, zglobovima i mišićima.
English: • bone loss in men receiving treatment for prostate cancer that increases their risk of fracture.
Croatian: • gubitka kostiju u muškaraca koji primaju terapiju protiv raka prostate koja povećava rizik od fraktura.
English: For more information about using Prolia, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Prolia pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: • bone loss in adults at increased risk of fractures who are treated long term with corticosteroid medicines given by mouth or injection.
Croatian: • gubitka kostiju u odraslih kod kojih postoji povećani rizik od frakture i koji se dugotrajno liječe kortikosteroidima peroralnom primjenom ili injekcijom.
English: Bone loss in men receiving treatment for prostate cancer
Croatian: Gubitak kostiju u muškaraca koji primaju terapiju protiv raka prostate
English: Prolia was also more effective at reducing the number of women who had fractures elsewhere in the body, including in the hip.
Croatian: Lijek Prolia bio je djelotvorniji u smanjenju frakturu drugih dijelova tijela u žena, uključujući kuk.
English: Prolia has been compared with placebo in one main study involving 242 men with osteoporosis.
Croatian: Lijek Prolia uspoređen je s placebom u jednom glavnom ispitivanju koje je obuhvatilo 242 muškarca s osteoporozom.
English: Prolia has been shown to be more effective than risedronate (a bisphosphonate medicine) at increasing bone density in one main study involving 795 adults treated with corticosteroid medicines.
Croatian: Lijek Prolia bio je djelotvorniji od risedronata (bisfosfonata) u povećanju gustoće kostiju u jednom glavnom ispitivanju koje je obuhvatilo 795 odraslih osoba liječenih kortikosteroidima.
English: In women who have been through the menopause Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip;
Croatian: Kod žena u postmenopauzi Prolia smanjuje rizik od fraktura kralježnice i drugih dijelova tijela, uključujući kuk;
English: Women who took Prolia had higher bone density (a measure of how strong the bones are) in the lumbar (lower) spine after 1 year of treatment than women on placebo.
Croatian: Žene koje su primale lijek Prolia imale su veću gustoću kostiju (mjerilo jačine kostiju) u lumbalnom (donjem) dijelu kralježnice nakon godinu dana liječenja u odnosu na žene koje su primale placebo.
English: Prolia has been shown to be more effective than placebo at treating bone loss in one main study involving 1,468 men receiving treatment for prostate cancer who were at an increased risk of fracture.
Croatian: Lijek Prolia bio je djelotvorniji od placeba u liječenju gubitka kostiju u jednom glavnom ispitivanju koje je obuhvatilo 1 468 muškaraca koji su primali terapiju protiv raka prostate i kod kojih je postojao povećani rizik od frakture.
English: Prolia has been shown to be more effective than placebo (a dummy treatment) at reducing fractures in two main studies involving a total of over 8,000 women with osteoporosis who had been through the menopause.
Croatian: Lijek Prolia bio je djelotvorniji od placeba (prividnog liječenja) u smanjenju fraktura u dvama glavnim ispitivanjima koja su obuhvatila ukupno više od 8 000 žena s osteoporozom nakon menopauze.
English: In the first of these studies, 2% of the women receiving Prolia had a new spine fracture after 3 years of treatment compared with 7% of the women receiving placebo.
Croatian: U prvom ispitivanju 2 % žena koje su primale lijek Prolia zadobilo je novu frakturu nakon tri godine liječenja u usporedbi sa 7 % žena koje su primale placebo.
English: In men who took Prolia bone density increased by 5.7% after 1 year of treatment compared with a 0.9% increase in men who took placebo.
Croatian: U muškaraca koji su primali lijek Prolia gustoća kostiju povećala se za 5,7 % nakon godinu dana terapije u usporedbi s povećanjem od 0,9 % kod muškaraca koji su primali placebo.
English: What benefits of Prolia have been shown in studies?
Croatian: Koje su koristi od lijeka Prolia utvrđene u ispitivanjima?
English: After 2 years, men who received Prolia had an increase in bone density in the lumbar spine that was 7% higher than in those who received placebo.
Croatian: Nakon dvije godine, u muškaraca koji su primali lijek Prolia zabilježeno je povećanje gustoće kostiju u lumbalnom dijelu kralježnice koje je bilo 7 % veće nego u muškaraca koji su primali placebo.
English: In patients who had been treated with corticosteroids for more than 3 months before the study, lumbar spine bone density increased by 3.6% after 1 year of treatment with Prolia compared with a 2.0% increase with risedronate.
Croatian: U bolesnika koji su se liječili kortikosteroidima duže od tri mjeseca prije ispitivanja, gustoća kostiju povećala se za 3,6 % nakon godinu dana terapije lijekom Prolia u usporedbi s povećanjem od 2,0 % kod terapije risedronatom.
English: For the full list of side effects and restrictions with Prolia, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Prolia potražite u uputi o lijeku.
English: In patients who had been treated with corticosteroids for up to 3 months before the study, bone density in the lumbar spine increased by 3.1% after 1 year of treatment with Prolia compared with a 0.8% increase with risedronate.
Croatian: U bolesnika liječenih kortikosteroidima do tri mjeseca prije ispitivanja gustoća kostiju povećala se za 3,1 % nakon godinu dana terapije lijekom Prolia u usporedbi s povećanjem od 0,8 % kod terapije risedronatom.
English: Prolia is given once every 6 months as a 60 mg injection under the skin in the thigh, abdomen (belly) or back of the arm. During treatment with Prolia, the doctor should ensure that the patient is receiving calcium and vitamin D supplements.
Croatian: Prolia se uzima jednom svakih šest mjeseci kao potkožna injekcija od 60 mg u bedro, abdomen (trbuh) ili vanjski dio nadlaktice.
English: How is Prolia used?
Croatian: Kako se Prolia primjenjuje?
English: None
Croatian: Nikakvih.
English: This will help to protect them against the disease.
Croatian: To će im pomoći u zaštiti od bolesti.
English: The local reactions lasted up to 25 days.
Croatian: Lokalne reakcije traju do 25 dana.
English: A booster is required after 12 months.
Croatian: Docjepljivanje je potrebno nakon 12 mjeseci.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and Quil-A) that enhance the response of the immune system.
Croatian: Cjepivo također sadržava „adjuvanse” (aluminijev hidroksid i Quil-A) kako bi se pojačao odgovor imunosnog sustava.
English: In most cases the reactions are diffuse swellings at the injection site which last no longer than one week.
Croatian: U većini slučajeva reakcije su difuzne otekline na mjestu davanja injekcije, koje ne traju dulje od jednog tjedna.
English: Further information on Zulvac BTV can be found on the Agency's website: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
Croatian: Više informacija o VMP-u Zulvac BTV nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
English: The serotype to be used in the vaccine is selected before manufacture depending on which type is circulating and causing disease at the time.
Croatian: Serotip koji treba upotrijebiti u cjepivu odabire se prije proizvodnje ovisno o tome koji soj najviše cirkulira i u tom trenutku izaziva pojavu bolesti.
English: What is the withdrawal period in food-producing animals?
Croatian: Koje je razdoblje karencije u životinja koje se upotrebljavaju za proizvodnju hrane?
English: They may also be nodules that can be felt under the skin of up to 60 cm2 in size which reduce with time but may persist for more than 50 days.
Croatian: Također se mogu pojaviti opipljivi potkožni čvorići (noduli) do 60 cm2, čija se veličina s vremenom smanjuje, ali mogu biti prisutni duže od 50 dana.
English: The withdrawal period for meat and milk from sheep and cattle treated with Zulvac BTV is ‘zero' days, which means there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso i mlijeko ovaca i goveda liječenih VMP-om Zulvac BTV iznosi „nula” dana, odnosno nema obveznog razdoblja čekanja.
English: The name of the medicine was changed to Zulvac BTV on 21 February 2019.
Croatian: Ime VMP-a promijenjeno je u Zulvac BTV 21. veljače 2019.
English: The vaccine is available as a suspension for injection and can only be obtained with a prescription.
Croatian: Cjepivo je dostupno kao suspenzija za injekciju i izdaje se samo na veterinarski recept.
English: the virus as ‘foreign' and makes antibodies against it.
Croatian: „strano tijelo” i proizvodi protutijela protiv njega.
English: When it is given to sheep or cattle, their immune system recognises
Croatian: Kada se primijeni u ovaca ili goveda, imunosni sustav životinje prepoznaje virus kao
English: This summary was last updated in December 2018.
Croatian: Sažetak je posljednji put ažuriran u 12. 2018.
English: Data on the effectiveness under field conditions of other bluetongue virus vaccines containing the individual serotypes or a combination of two serotypes were also taken into account.
Croatian: U obzir su uzeti i podatci o učinkovitosti ostalih cjepiva protiv virusa bolesti plavog jezika u terenskim uvjetima, koji sadržavaju pojedine serotipove ili kombinaciju dvaju serotipa.
English: The vaccine contains inactivated (killed) bluetongue virus.
Croatian: Cjepivo sadržava inaktivirani (umrtvljeni) virus bolesti plavog jezika.
English: Zulvac BTV received a marketing authorisation valid throughout the EU on 25 April 2017.
Croatian: Za VMP Zulvac BTV izdano je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 25. travnja 2017.
English: 1 Previously known as Zulvac BTV Ovis.
Croatian: 1 Prethodno poznat kao Zulvac BTV Ovis.
English: It is also the time required after administration of a medicine before milk may be used for human consumption.
Croatian: To je također vrijeme koje treba proći nakon primjene VMP-a prije nego što ljudi smiju konzumirati mlijeko.
English: The vaccine is given as two injections under the skin for sheep and in the muscle for cattle.
Croatian: Cjepivo se daje ovcama ubrizgavanjem dviju injekcija pod kožu, a govedima u mišić.
English: The vaccine can prevent the presence of serotypes 1 or 8 in the blood and reduce levels of serotype 4.
Croatian: Cjepivom se može spriječiti prisutnost serotipa 1 ili 8 u krvi te se mogu smanjiti razine serotipa 4.
English: For sheep protection starts 3 weeks after the initial course of two injections and lasts for one year.
Croatian: Zaštita u ovaca počinje tri tjedna nakon početne primjene dviju injekcija i traje jednu godinu.
English: Zulvac BTV contains bluetongue virus that has been inactivated so that it cannot cause the disease.
Croatian: Zulvac BTV sadržava virus bolesti plavog jezika koji je inaktiviran tako da ne može uzrokovati bolest.
English: The first injection is given from 6 weeks of age for sheep and from 12 weeks of age for cattle; and a second injection is given 3 weeks later.
Croatian: Prva se injekcija daje ovcama starosti od 6 tjedana nadalje, a govedima od 12 tjedana nadalje.
English: Zulvac BTV is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Croatian: Zulvac BTV je cjepivo koje se primjenjuje u ovaca i goveda radi zaštite od bolesti plavog jezika, infekcije koju uzrokuje virus bolesti plavog jezika koji prenose mušice.
English: The European Medicines Agency decided that Zulvac BTV' benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od VMP-a Zulvac BTV nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The most common side effects with Zulvac BTV in cattle (which may affect more than 1 in 10 animals) are local reactions at the injection site and a short-lived increase in body temperature, up to 2.7˚C, during the 2 days after vaccination.
Croatian: Najčešće nuspojave pri primjeni VMP-a Zulvac BTV u goveda (koje se mogu pojaviti u više od 1 od 10 životinja) su lokalne reakcije na mjestu davanja injekcije i kratkotrajni porast tjelesne temperature do 2,7˚C tijekom dva dana nakon cijepljenja.
English: For more information about using Zulvac BTV, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacija o primjeni VMP-a Zulvac BTV pogledajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: The most common side effects with Zulvac BTV in sheep (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature, up to 1.6˚C, during the 2 days after vaccination and local reactions at the injection site.
Croatian: Najčešće nuspojave pri primjeni VMP-a Zulvac BTV u ovaca (koje se mogu pojaviti u više od 1 od 10 životinja) su kratkotrajni porast tjelesne temperature do 1,6˚C tijekom dva dana nakon cijepljenja i lokalne reakcije na mjestu davanja injekcije.
English: Zulvac BTV is a vaccine.
Croatian: Zulvac BTV je cjepivo.
English: Zulvac BTV (inactivated bluetongue vaccine containing either serotype 1, 4 or 8)1
Croatian: Zulvac BTV (inaktivirano cjepivo protiv virusa bolesti plavog jezika koje sadržava serotipove 1, 4 ili 8)1
English: An overview of Zulvac BTV and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Zulvac BTV i zašto je odobren u EU-u
English: A laboratory study with lambs vaccinated with serotype 4 showed the vaccine to reduce levels of serotype 4 in the blood for at least 12 months whilst studies with serotype 1 and 8 showed absence of the respective serotypes after one year.
Croatian: U laboratorijskom ispitivanju na janjadi cijepljenoj serotipom 4 utvrdilo se da se cjepivom smanjuju razine serotipa 4 u krvi tijekom razdoblja od najmanje 12 mjeseci, dok se ispitivanjima na serotipovima 1 i 8 pokazala odsutnost dotičnih serotipova nakon jedne godine.
English: Why is Zulvac BTV authorised in the EU?
Croatian: Zašto je Zulvac BTV odobren u EU-u?
English: For cattle protection starts 15 days after the initial course of two injections for serotype 1 whilst protection starts 25 days after the initial course of two injections for serotype 8.
Croatian: Zaštita u goveda počinje 15 dana nakon početne primjene dviju injekcija za serotip 1, dok za serotip 8 zaštita počinje 25 dana nakon početne primjene dviju injekcija.
English: What is Zulvac BTV and what is it used for?
Croatian: Što je Zulvac BTV i za što se primjenjuje?
English: When used in sheep the vaccine contains one of the following three vaccine strains: BTV serotype 1, BTV serotype 4 and BTV serotype 8.When used in cattle the vaccine contains either BTV serotype 1 or BTV serotype 8.
Croatian: Kad se primjenjuje u ovaca, sadržava jedan od sljedećih triju sojeva cjepiva: BTV serotip 1, BTV serotip 4 i BTV serotip 8.
English: Zulvac BTV contains bluetongue virus of one type selected from serotypes 1, 4 and 8.
Croatian: Zulvac BTV sadržava virus bolesti plavog jezika jednog soja odabranog među serotipovima 1, 4 i 8.
English: What are the risks associated with Zulvac BTV?
Croatian: Koji su rizici povezani s VMP-om Zulvac BTV?
English: Further laboratory studies showed protection lasts for one year for each serotype.
Croatian: Dodatnim laboratorijskim ispitivanjima pokazalo se da zaštita za svaki serotip traje jednu godinu.
English: Further laboratory studies showed protection lasts for one year for the respective serotypes.
Croatian: Dodatnim laboratorijskim ispitivanjima pokazalo se da zaštita traje godinu dana za dotične serotipove.
English: Laboratory studies were conducted with the individual serotypes 1, 4 and 8 as well as with the combination of 1 and 8 in sheep which showed that protection starts three weeks after completion of the initial course of two injections for each serotype.
Croatian: Laboratorijskim ispitivanjima provedenima pri pojedinačnoj primjeni serotipova 1, 4 i 8 i kombinacije serotipova 1 i 8 u ovaca pokazalo se da se zaštita od bolesti stvara tri tjedna nakon završetka početne terapije dvjema injekcijama za svaki serotip.
English: Other information about Zulvac BTV?
Croatian: Ostale informacije o VMP-u Zulvac BTV