FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 800 mg of sevelamer carbonate - The other ingredients are microcrystalline cellulose, sodium chloride and zinc stearate.
Croatian: - Drugi sastojci su mikrokristalična celuloza, natrijev klorid i cinkov stearat.
English: The use of sevelamer carbonate powder in patients with a history of difficulty swallowing should be considered.
Croatian: U bolesnika koji su prethodno imali poteškoća s gutanjem treba razmotriti primjenu sevelamerkarbonata u obliku praška.
English: Other side effects have been reported in patients taking Renvela: Very common: vomiting, upper abdominal pain, nausea Common (may affect up to 1 in 10 people): diarrhoea, stomach ache, indigestion, flatulence Not known: cases of itching, rash, slow intestine motility (movement)
Croatian: Poremećaji probavnog sustava mučnina, povraćanje, bol u gornjem dijelu abdomena, konstipacija proljev, dispepsija, flatulencija, bol u abdomenu opstrukcija crijeva, ileus/subileus, perforacija crijeva gastrointestinalna hemoragija* ulceracija crijeva* gastrointestinalna nekroza* kolitis*
English: In patients with secondary hyperparathyroidism sevelamer carbonate should be used within the context of a multiple therapeutic approach, which could include calcium as supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the iPTH levels.
Croatian: Bolesnici sa sekundarnom hiperparatireozom trebaju uzimati sevelamerkarbonat u sklopu multiterapijskog pristupa koji može uključivati nadomjestke kalcija te 1,25-dihidroksi vitamin D3 ili neki od njegovih analoga, kako bi se snizile razine iPTH-a.
English: • swallowing disorders
Croatian: • poremećajima gutanja
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po vrećici, tj. zanemarive količine natrija.
English: • you have bowel obstruction
Croatian: • ako patite od blokade crijeva
English: Each sachet contains 0.8 g of sevelamer carbonate.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna vrećica sadrži 0,8 g sevelamerkarbonata.
English: Nederland sanofi-aventis Netherlands B.V. Tel: +31 20 245 4000
Croatian: Slovenija sanofi-aventis d.o.o. Tel: +386 1 560 4800
English: Protection starts one week after vaccination and lasts 12 months.
Croatian: Zaštita započinje tjedan dana nakon cijepljenja i traje 12 mjeseci.
English: What is Eravac and what is it used for?
Croatian: Što je Eravac i za što se koristi?
English: The studies showed the vaccine to be effective in reducing death.
Croatian: Ispitivanja su pokazala da je cjepivo učinkovito u smanjenju smrtnosti.
English: This summary was last updated in December 2019.
Croatian: Pregled je posljednji put ažuriran u prosincu 2019.
English: Further information on Eravac can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/eravac.
Croatian: Više informacija o VMP-u Eravac nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/eravac.
English: If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Croatian: Ako bol potraje dulje od 12 sati nakon liječničkog pregleda, treba ponovno potražiti pomoć liječnika.
English: It is usually a fatal disease resulting in the formation of blood clots.
Croatian: To je obično smrtonosna bolest koja uzrokuje stvaranje krvnih ugrušaka.
English: Why is Eravac approved in the EU?
Croatian: Zašto je Eravac odobren u EU-u?
English: If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected.
Croatian: Ako si netko slučajno ubrizga ovaj VMP, mora potražiti hitnu medicinsku pomoć čak i ako je ubrizgana vrlo mala količina.
English: The slight temperature increase resolves spontaneously without treatment within 5 days and the local reactions resolve spontaneously within 24 hours.
Croatian: Taj neznatni porast temperature spontano nestaje bez ikakve terapije u roku od 5 dana, a lokalne reakcije nestaju spontano u roku od 24 sata.
English: Eravac contains an adjuvant (mineral oil) to enhance the immune response.
Croatian: Eravac sadrži adjuvans (mineralno ulje) kako bi se pojačao imunosni odgovor.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or fingerthis could result in the loss of the finger if prompt medical attention is not given.
Croatian: Slučajno ubrizgavanje može prouzročiti jaku bol i oticanje, naročito ako se cjepivo ubrizga u zglob ili prst, što može rezultirati gubitkom zahvaćenog prsta ako se ne pruži hitna medicinska pomoć.
English: Eravac is a vaccine.
Croatian: Eravac je cjepivo.
English: Vaccines work by preparing the immune system (the body's natural defences) to defend itself against a specific disease.
Croatian: Cjepiva djeluju tako što pripremaju imunosni sustav (prirodnu obranu tijela) za obranu od određene bolesti.
English: What are the risks associated with Eravac?
Croatian: Koji su rizici povezani s VMP-om Eravac?
English: The European Medicines Agency decided that Eravac's benefits are greater than its risks and that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove odlučila je da koristi od VMP-a Eravac nadmašuju s njim povezane rizike te se može izdati odobrenje za njegovu primjenu u EU-u.
English: The vaccine is given to rabbits from 30 days of age as a single injection under the skin of the side of the chest.
Croatian: Cjepivo se daje kunićima starijima od 30 dana u obliku jedne injekcije koja se daje ispod kože s bočne strane prsa.
English: Eravac received a marketing authorisation valid throughout the EU for Eravac on 22 September 2016.
Croatian: Za VMP Eravac izdano je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 22. rujna 2016.
English: The withdrawal period for meat from rabbits treated with Eravac for is ‘zero' days, which means there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso kunića liječenih VMP-om Eravac iznosi „nula” dana, odnosno nema obveznog razdoblja čekanja.
English: In the future if rabbits come into contact with rabbit haemorrhagic disease type 2 virus, these antibodies, together with other components of the immune system, will be able to destroy the virus and help protect against the disease.
Croatian: Ako kunići u budućnosti dođu u kontakt s virusom hemoragijske bolesti kunića tipa 2, ta će protutijela zajedno s drugim dijelovima imunosnog sustava moći uništiti virus i pomoći pri zaštiti od bolesti.
English: Rabbits should be revaccinated one year after vaccination.
Croatian: Kuniće treba ponovno cijepiti godinu dana nakon prvog cijepljenja.
English: An overview of Eravac and why it is authorised in the EU
Croatian: Pregled VMP-a Eravac i zašto je odobren u EU-u
English: The effectiveness of the vaccine was initially compared with that of a placebo (dummy) vaccine in three laboratory studies involving 301 rabbits.
Croatian: Učinkovitost cjepiva na početku je uspoređena s učinkovitošću placeba (prividnog liječenja) u trima laboratorijskim ispitivanjima na 301 kuniću.
English: The most common side effects with Eravac (which may affect more than 1 in 10 rabbits) are a shortlived increase in body temperature to slightly above 40 ºC, which may occur between two or three days after vaccination, and nodules or swellings (less than 2 cm in size) at the injection site.
Croatian: Najčešće su nuspojave povezane s VMP-om Eravac (koje se mogu javiti u više od 1 na 10 kunića) prolazni porast tjelesne temperature na neznatno iznad 40ºC do kojeg može doći dva do tri dana nakon cijepljenja te kvržice ili otekline (manje od 2 cm) na mjestu injektiranja.
English: When it is given to rabbits, the immune system recognises the virus in the vaccine as ‘foreign' and makes antibodies against it.
Croatian: Kada se primijeni u kunića, imunosni sustav životinje prepoznaje virus u cjepivu kao „strano tijelo” i proizvodi protutijela protiv njega.
English: RHD type 2 virus differs from the classic form of RHD virus since the course of disease is more prolonged, death occurs later and over a longer period and is more severe in young rabbits.
Croatian: Virus RHD tipa 2 razlikuje se od klasičnog soja RHD virusa jer je tijek bolesti dulji, do smrti dolazi kasnije i tijekom duljeg razdoblja i bolest je teža u mladih kunića.
English: Other information about Eravac?
Croatian: Ostale informacije o VMP-u Eravac
English: Eravac is available as an injection and can only be obtained with a prescription.
Croatian: Eravac je dostupan kao injekcija i izdaje se samo na veterinarski recept.
English: For further information, see the package leaflet.
Croatian: Za dodatne informacije pogledajte uputu o VMP-u.
English: Eravac is a veterinary vaccine used in rabbits to reduce death due to the rabbit haemorrhagic disease (RHD), caused by the variant of RHD virus called RHD type 2 (RHDV2).
Croatian: Eravac je veterinarsko cjepivo koje se daje kunićima radi smanjenja smrtnosti zbog hemoragijske bolesti kunića (RHD) koju uzrokuje soj virusa RHD koji se naziva RHD tipa 2 (RHDV2).
English: After vaccination the rabbits were artificially infected with RHDV2.
Croatian: Nakon cijepljenja kunići su umjetno zaraženi virusom RHD tipa 2.
English: What benefits of Eravac have been shown in studies?
Croatian: Koje su koristi od VMP-a Eravac utvrđene u ispitivanjima?
English: In the third study all Eravac-vaccinated rabbits survived, compared with less than 70% of the rabbits in the control group, when rabbits were artificially infected with RHDV2 nine months after vaccination.
Croatian: U trećem su ispitivanju svi kunući koji su primili cjepivo Eravac preživjeli u usporedbi sa stopom preživljavanja manjom od 70 % u kontrolnoj skupini, kada su kunići umjetno zaraženi virusom RHD tipa 2 devet mjeseci nakon cijepljenja.
English: In a later laboratory study involving 48 rabbits, 95% of Eravac vaccinated rabbits survived, compared to 65% of rabbits given placebo, following artificial infection with RHDV2 at 12 months after vaccination.
Croatian: U kasnijem laboratorijskom ispitivanju koje je obuhvaćalo 48 kunića, 95 % kunića koji su primili cjepivo Eravac preživjeli su u usporedbi sa 65 % kunića koji su primili placebo nakon što je zaraza virusom RDH tipa 2 umjetno izazvana 12 mjeseci nakon cijepljenja.
English: Eravac contains rabbit haemorrhagic disease type 2 virus (RHDV2) strain V-1037, which has been inactivated so it cannot cause the disease.
Croatian: Eravac sadrži virus hemoragijske bolesti kunića tipa 2 (RHDV2), soj V1037, koji je inaktiviran kako ne bi uzrokovao bolest.
English: In one study all Eravac-vaccinated rabbits survived, compared with a 37% survival rate in the group that received the placebo vaccine.
Croatian: U jednom su ispitivanju svi kunići koji su primili cjepivo Eravac preživjeli u usporedbi sa stopom preživljavanja od 37 % u skupini koja je primila placebo.
English: How is Eravac used?
Croatian: Kako djeluje Eravac?
English: Eravac contains inactivated rabbit haemorrhagic disease type 2 virus, strain V-1037, as the active substance.
Croatian: Eravac sadrži inaktivirani virus hemoragijske bolesti kunića tipa 2, soj V-1037, kao djelatnu tvar.
English: In the second study survival of Eravac-vaccinated rabbits was 93% compared with 50% for rabbits given placebo.
Croatian: U drugom je ispitivanju stopa preživljenja među kunićima koji su primili cjepivo Eravac bila 93 % u usporedbi sa stopom od 50 % u kunića koji su primili placebo.
English: Eravac (rabbit haemorrhagic disease vaccine, inactivated)
Croatian: Eravac (cjepivo protiv hemoragijske bolesti kunića,
English: How does Eravac work?
Croatian: Kako se Eravac koristi?
English: The injection should not be repeated.
Croatian: Injekcija se ne smije ponavljati.
English: Forceris may be harmful for the unborn child.
Croatian: Forceris može biti štetan za nerođenu djecu.
English: Excess iron is stored mainly in the liver.
Croatian: Višak željeza uglavnom se pohranjuje u jetri.
English: Forceris is a veterinary medicine.
Croatian: Forceris je veterinarsko-medicinski proizvod.
English: Further information on Forceris can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/forceris.
Croatian: Više informacija o VMP-u Forceris nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/forceris.
English: It is given as a single injection into the muscle behind the ear of piglets between 24 and 96 hours old.
Croatian: Daje se kao jednokratna injekcija u mišić iza uha praščića u dobi između 24 i 96 sati starosti.
English: What is Forceris and what is it used for?
Croatian: Što je Forceris i za što se primjenjuje?
English: Forceris must not be given to piglets suspected to have insufficient levels of vitamin E or selenium.
Croatian: Forceris se ne smije davati praščićima kod kojih se sumnja na nedovoljne razine vitamina E ili selena.
English: In case of skin or eye contact the affected area should be rinsed immediately with water.
Croatian: U slučaju kontakta s kožom ili očima, zahvaćeno se područje treba odmah isprati vodom.
English: The withdrawal period for meat from pigs treated with Forceris is 70 days.
Croatian: Razdoblje karencije za meso svinja liječenih VMP-om Forceris iznosi 70 dana.
English: Why is Forceris authorised in the EU?
Croatian: Zašto je Forceris odobren u EU-u?
English: As a result it is able to kill the parasites at all stages of their development and prevent the symptoms of coccidiosis and the spread of infection.
Croatian: Stoga može ubiti parazite u svim stadijima razvoja te sprječava simptome kokcidioze i širenje infekcije.
English: Forceris received a marketing authorisation valid throughout the EU on 23 April 2019.
Croatian: Forceris je dobio odobrenje za stavljanje u promet koje je na snazi u EU-u od 23/04/2019.
English: Care should be taken to avoid accidental self-injection, which may cause local reactions such as irritation, granulomas, or severe anaphylactic (allergic) reactions in sensitive people.
Croatian: Potreban je oprez da se izbjegne nehotično samoinjiciranje, koje može izazvati lokalne reakcije poput iritacije, granuloma ili ozbiljne anafilaktičke (alergijske) reakcije u osjetljivijih osoba.
English: Forceris (toltrazuril/gleptoferron)
Croatian: Forceris (toltrazuril/gleptoferon)
English: Following injection into the muscle, gleptoferron is absorbed and broken down to release iron for use and/or storage depending on the nutritional need of the piglet.
Croatian: Nakon injekcije u mišić, gleptoferon se apsorbira i razgrađuje te otpušta željezo za uporabu ili skladištenje, ovisno o nutritivnoj potrebi praščića.
English: Other information about Forceris
Croatian: Ostale informacije o VMP-u Forceris
English: The European Medicines Agency decided that Forceris' 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 VMP-a Forceris nadmašuju s njim povezane rizike te da VMP može biti odobren za primjenu u Europskoj uniji.
English: Toltrazuril is an antiparastic medicine which interferes with the enzymes needed by coccidia parasites to produce energy.
Croatian: Toltrazuril je protuparazitski VMP koji ometa enzime potrebne parazitima kokcidioze za proizvodnju energije.
English: Forceris (toltrazuril/gleptoferron) EMA/146411/2019
Croatian: Forceris (toltrazuril/gleptoferon) EMA/265628/2019
English: An overview of Forceris and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Forceris i zašto je odobren u EU-u
English: People who are hypersensitive (allergic) to iron compounds or toltrazuril should avoid contact with Forceris.
Croatian: Osobe koje su preosjetljive (alergične) na spojeve sa željezom ili na toltrazuril trebaju izbjegavati kontakt s VMP-om Forceris.
English: Forceris is available as an injection and can only be obtained with a prescription.
Croatian: Forceris je dostupan kao injekcija i izdaje se samo na veterinarski recept.
English: In a field study performed in 3 EU countries and involving over 1,500 piglets, a single intramuscular injection of Forceris given at 24 to 96 hours of age was effective in preventing iron deficiency anaemia,
Croatian: U terenskom ispitivanju provedenom u tri države EU-a koje je uključivalo više od 1 500 praščića, jednokratna injekcija VMP-a Forceris u mišić primijenjena u dobi od 24 do 96 sati starosti pokazala se učinkovitom u sprječavanju anemije uzrokovane manjkom željeza, smanjenju izlučivanja oocista i
English: Skin and eye contact with Forceris can cause irritation and should be avoided.
Croatian: Kontakt VMP-a Forceris s kožom i očima može izazvati iritaciju te ga treba izbjegavati.
English: Hands should be washed after using the medicine.
Croatian: Nakon primjene VMP-a treba oprati ruke.
English: What are the risks associated with Forceris?
Croatian: Koji su rizici povezani s VMP-om Forceris?
English: Iron is an essential nutrient needed to make haemoglobin to transport oxygen in the blood, as well as certain key enzymes, and may be lacking in the diet of piglets raised under intensive farming conditions.
Croatian: Željezo je ključna hranjiva tvar za proizvodnju hemoglobina koji prenosi kisik u krvi, kao i određeni enzimi, te njegova količina može biti nedostatna u prehrani praščića u uvjetima intenzivnog uzgoja.
English: reducing oocyst excretion and preventing diarrhoea associated with coccidiosis caused by the coccidia parasite Cystoisospora suis, in comparison with giving iron only (as gleptoferron) on the first day after birth.
Croatian: sprječavanju proljeva povezanog s kokcidiozom kojeg uzrokuje parazit Cystoisospora suis, u usporedbi s primjenom samo željeza (u obliku gleptoferona) prvi dan nakon rođenja.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju nehotičnog samoinjiciranja potrebno je odmah potražiti savjet liječnika te mu pokazati uputu o proizvodu ili etiketu VMP-a.
English: Pregnant women and women intending to conceive should avoid contact with the medicine, especially accidental self-injection.
Croatian: Trudnice i žene koje namjeravaju zatrudnjeti trebaju izbjegavati kontakt s ovim VMP-om, te primijeniti poseban oprez da spriječe slučajno samoinjiciranje.
English: It is used in young piglets on farms which have been affected by the parasitic infection coccidiosis in the past to prevent diarrhoea caused by a new coccidiosis infection, to reduce spread of the infection through passage of oocysts (disease spores) in faeces, and at the same time to prevent iron deficiency anaemia due to lack of iron in the piglets' diet.
Croatian: Primjenjuje se na praščićima na gospodarstvima na kojima je prethodno zabilježena parazitska infekcija kokcidioza, za sprječavanje proljeva uzrokovanog ponovnom infekcijom kokcidioze, za ograničavanje širenja infekcije kroz oociste (spore bolesti) u stolici te istovremeno za suzbijanje anemije uzrokovane manjkom željeza u prehrani praščića.
English: What benefits of Forceris have been shown in studies?
Croatian: Koje su koristi od VMP-a Forceris utvrđene u ispitivanjima?
English: Forceris contains the active substances toltrazuril and gleptoferron (an iron-containing compound).
Croatian: Forceris sadrži djelatne tvari toltrazuril i gleptoferon (spoj koji sadrži željezo).
English: How is Forceris used?
Croatian: Kako djeluje Forceris?
English: For more information about using Forceris, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Više informacija o primjeni VMP-a Forceris pročitajte u uputi o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: For the full list of side effects and restrictions of Forceris, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom VMP-a Forceris potražite u uputi o VMPu.
English: The other active substance in Forceris, gleptoferron, is an iron-containing compound.
Croatian: Druga djelatna tvar VMP-a Forceris, gleptoferon, spoj je koji sadrži željezo.
English: The Czech Republic is the reference Member State and Austria, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and the United Kingdom are concerned Member States.
Croatian: Republika Češka je referentna zemlja članica, a Austrija, Danska, Francuska, Njemačka, Irska, Italija, Nizozemska, Portugal, Španjolska i Ujedinjeno Kraljevstvo su zemlje članice u pitanju.
English: 12 August 2013
Croatian: 12. kolovoza 2013.
English: The decentralised procedure started on 29 November 2010.
Croatian: Decentralizirani postupak je započeo 29. studenog 2010.
English: The opinion was converted into a Decision by the European Commission on 12 August 2013.
Croatian: Mišljenje je promijenjeno u Odluku Europske komisije 12. kolovoza 2013.
English: The Committee appointed Mr J. Schefferlie as rapporteur and Dr J. Bureš as co-rapporteur.
Croatian: Odbor je imenovao g. J. Schefferlieja kao izvjestitelja i dr. J. Bureša kao pomoćnog izvjestitelja.
English: Veterinary Medicines and Product Data Management
Croatian: Upravljanje podacima o veterinarskim lijekovima i proizvodima
English: International non-proprietary name (INN): amoxicillin and clavulanic acid
Croatian: Međunarodni nezaštićeni naziv (INN, eng. international non-proprietary name): amoksicilin i klavulanska kiselina
English: Committee for medicinal products for veterinary use (CVMP)
Croatian: Committee for Medicinal Products for Veterinary Use)
English: The referral procedure started on 11 July 2012.
Croatian: Postupak upućivanja započeo je 11. srpnja 2012.
English: Written explanations were provided by the applicant on 11 September 2012 and 6 February 2013.
Croatian: Podnositelj zahtjeva predao je pisana objašnjenja 11. rujna 2012. i 6. veljače 2013.
English: Potential serious risks were identified during the decentralised procedure by the Netherlands and the United Kingdom regarding the environmental safety of the product.
Croatian: Tijekom decentraliziranog postupka Nizozemska i Ujedinjeno Kraljevstvo ustanovili su potencijalne ozbiljne rizike koji se odnose na sigurnost lijeka za okoliš.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 2 May 2012.
Croatian: Do 210. dana ta su pitanja ostala neriješena i stoga je prema Članku 33(1) Direktive 2001/82/EZ 2. svibnja 2012. započelo upućivanje Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za veterinarske lijekove (CMD(v), eng.
English: Oral explanations were given on 9 April 2013.
Croatian: Usmena objašnjenja dana su 9. travnja 2013.
English: and gastrointestinal infections caused by Clostridium spp., E. coli and Salmonella spp.
Croatian: Actinobacillus pleuropneumoniae, Pasteurella spp, Streptococcus spp. i infekcija gastrointestinalnog trakta uzrokovanih s Clostridium spp., E. coli i Salmonella spp.
English: Day 60 of the CMD(v) procedure was on 29 June 2012, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Croatian: Dan 60. postupka pri CMD(v) bio je 29. lipnja 2012. i pošto zemlje članice u pitanju nisu postigle sporazum u vezi lijeka, postupak je upućen u CVMP (Odbor za veterinarsko-medicinske proizvode, eng.
English: This is a generic application according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125 mg/g powder for use in drinking water authorised in the Czech Republic (MA No. 96/069/98-C).
Croatian: To je generički zahtjev prema Članku 13(1) Direktive 2001/82/EZ, kako je izmijenjeno, koji se odnosi na referentni lijek Amoksiklav 500/125 mg/g prašak za uporabu u vodi za piće koji je odobren u Republici Češkoj (MA No.