FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Entacapone Orion
Croatian: Nemojte uzimati Entacapone Orion
English: In addition, Entacapone Orion taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Croatian: Dodatno, Entacapone Orion uzet s levodopom može izazvati jaku pospanost ili se može dogoditi da iznenada utonete u san.
English: If you forget to take Entacapone Orion
Croatian: Ako ste zaboravili uzeti Entacapone Orion
English: Elderly No dosage adjustment of entacapone is required for elderly.
Croatian: Starije osobe Starijim osobama nije potrebno posebno prilagođavati doziranje entakapona.
English: Entacapone Orion is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Croatian: Orion se uzima zajedno s lijekovima koji sadrže levodopu (ili kombinacija levodope/karbidope ili kombinacija levodope/benzerazida).
English: Each film-coated tablet contains 200 mg entacapone.
Croatian: Jedna filmom obložena tableta sadržava 200 mg entakapona.
English: Entacapone Orion contains soya lecithin
Croatian: Orion sadrži sojin lecitin
English: Orion Pharma AS Tlf.
Croatian: United Kingdom Orion Pharma (UK) Ltd.
English: Daily ON time (Mean ±SD)
Croatian: Tablica 2. Dnevno trajanje ON faze (srednja vrijednost ± SD)
English: Each tablet contains 200 mg of entacapone,
Croatian: Svaka tableta sadržava 200 mg entakapona,
English: Entacapone Orion 200 mg film-coated tablets
Croatian: Entacapone Orion 200 mg filmom obložene tablete
English: • being sick (vomiting), diarrhoea, abdominal pain, constipation, dry mouth;
Croatian: • povraćanje, proljev, bol u trbuhu, zatvor, suha usta;
English: Microcrystalline cellulose Croscarmellose sodium Povidone
Croatian: Jezgra tablete: celuloza, mikrokristalična karmelozanatrij, umrežena povidon magnezijev stearat
English: - The other ingredients in the tablet core are microcrystalline cellulose, croscarmellose sodium,
Croatian: - Drugi sastojci su mikrokristalična celuloza, umrežena karmelozanatrij, povidon, i magnezijev stearat.
English: Entacapone Orion 200 mg film-coated tablets entacapone
Croatian: Entacapone Orion 200 mg filmom obložene tablete entakapon
English: The recommended dose of Entacapone Orion is one 200 mg tablet with each levodopa dose.
Croatian: Oriona je jedna tableta od 200 mg, uz svaku dozu levodope.
English: - Hepatic impairment.
Croatian: - Oštećenje jetre.
English: Hence, to reduce levodopa-related dopaminergic adverse reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment.
Croatian: Zato tijekom prvih dana ili prvih tjedana od početka liječenja entakaponom često je potrebno prilagoditi doziranje levodope, kako bi se smanjile dopaminergičke nuspojave povezane s levodopom, npr. diskinezije, mučnina, povraćanje i halucinacije.
English: How to take Entacapone Orion
Croatian: Kako uzimati Entacapone Orion
English: Yellow iron oxide (E 172) Red iron oxide (E 172) Titanium dioxide (E 171)
Croatian: Ovojnica tablete: polivinilni alkohol, djelomično hidroliziran talk makrogol sojin lecitin željezov oksid, žuti (E172) željezov oksid, crveni (E172) titanijev dioksid (E171)
English: Usually side effects caused by Entacapone Orion are mild to moderate.
Croatian: Orionom obično su blage do umjerene.
English: Skin, hair, beard and nail discolourations
Croatian: Promjene boje kože, kose, brade i noktiju Poremećaji bubrega i mokraćnog sustava Vrlo često:
English: Colitis
Croatian: Urtikarija
English: Thus, entacapone should be administered cautiously to patients being treated with medicinal products metabolised by catechol-Omethyl transferase (COMT), e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
Croatian: rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopa i apomorfin (vidjeti također dio 4.5).
English: Each tablet contains 200 mg of entacapone.
Croatian: Jedna tableta sadržava 200 mg entakapona.
English: How to store Entacapone Orion
Croatian: Kako čuvati Entacapone Orion
English: Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment from controlled trials in which entacapone was discontinued abruptly.
Croatian: U kontroliranim ispitivanjima u kojima je primjena entakapona bila naglo prekinuta, nisu zabilježeni ni NMS niti rabdomioliza u vezi s liječenjem entakaponom.
English: • abdominal pain.
Croatian: • bol u trbuhu.
English: If you forget to take the Entacapone Orion tablet with your levodopa dose, you should continue the treatment by taking the next Entacapone Orion tablet with your next levodopa dose.
Croatian: Orion tablete sa svojom sljedećom dozom levodope.
English: The doses of other antiparkinsonian medicinal products may need to be adjusted when entacapone treatment is initiated.
Croatian: Orion, može biti potrebno prilagođavanje doze drugih lijekova u terapiji Parkinsonove bolesti.
English: Breast-feeding
Croatian: Entacapone
English: Urine discoloration General disorders and administration site conditions Common:
Croatian: Promjena boje mokraće Opći poremećaji i reakcije na mjestu primjene Često:
English: White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP)
Croatian: Bijele polietilenske (HDPE) bočice visoke gustoće s bijelim sigurnosnim polipropilenskim (PP) zatvaračem koje sadrže 30, 60, 100 ili 175 tableta.
English: Magnesium stearate
Croatian: Nuspojave izazvane Entacapone
English: Therefore, the use of Entacapone Orion in children or adolescents cannot be recommended.
Croatian: Oriona u djece ili adolescenata.
English: The dose of other medicines to treat Parkinson's disease may need to be adjusted when you start taking Entacapone Orion.
Croatian: U početku liječenja entakaponom može biti potrebno prilagođavanje doze drugih lijekova za Parkinsonovu bolest.
English: This summary was last updated in February 2016.
Croatian: Ovaj sažetak je posljednji put ažuriran u veljači 2016.
English: This will help protect against the disease.
Croatian: To pomaže pri zaštiti od bolesti.
English: Hands and equipment should be disinfected after use.
Croatian: Nakon uporabe potrebno je dezinficirati ruke i opremu.
English: The vaccine may spread to in-contact birds.
Croatian: Cjepivo se može širiti kontaktom među pticama.
English: Antibiotic treatment should not be given within one week before or after vaccination.
Croatian: Antibiotska terapija ne smije se davati unutar jednog tjedan prije ili nakon cijepljenja.
English: The bacterium is alive, but it has been weakened by removal of a gene (aroA) so that it does not cause disease, which makes it suitable for use in a vaccine.
Croatian: Bakterija je živa, no oslabljena je uklanjanjem gena (aroA) tako da ne uzrokuje bolest, što je čini pogodnom za primjenu u cjepivu.
English: The field study with over 200,000 commercial broilers showed a significant reduction in colibacillosis lesions and deaths in vaccinated animals.
Croatian: Terenska ispitivanja s više od 200 000 komercijalnih nesilica pokazala su značajno smanjenje kolibaciloznih lezija i smrti cijepljenih životinja.
English: Animals undergoing antibacterial or immunosuppressive treatment (treatment that reduces the activity of the immune system) should not be vaccinated.
Croatian: Životinje koje su na antibakterijskoj ili imunosupresivnoj terapiji (terapiji koja smanjuje djelovanje imunosnog sustava) ne trebaju biti cijepljene.
English: It contains the live bacteria Escherichia coli, type O78, strain EC34195 with a gene (aroA) deleted.
Croatian: Sadrži živu bakteriju Escherichia coli, tip O78, soj EC34195 s obrisanim genom (aroA).
English: The vaccine should not be used within six weeks before the start of the laying period or in birds in lay (currently producing eggs).
Croatian: Cjepivo se ne smije koristiti unutar šest tjedana prije početka razdoblja nesenja ili u ptica koje nesu (trenutno proizvode jaja).
English: Personnel involved in attending vaccinated animals should follow general hygiene principles and take particular care in handling litter from vaccinated animals.
Croatian: Osoblje zaduženo za brigu o cijepljenim životinjama treba slijediti opća higijenska načela i posebno voditi brigu prilikom zbrinjavanja otpada cijepljene peradi.
English: The vaccine, which is for use in broiler chickens (reared for meat), future layers or breeders (reared for egg production) and turkeys, helps reduce injuries and deaths caused by the infection.
Croatian: Cjepivo koje se koristi u brojler pilića (uzgajanima za meso), budućim nesilicama ili roditeljima (uzgajanima za jaja) te puranima, pomaže u smanjenju ozljeda i smrti koje uzrokuje infekcija.
English: Immunosuppressed people should not be present during administration of the vaccine.
Croatian: Osobe s imunosupresijom ne bi smjele biti prisutne za vrijeme primjene cjepiva.
English: In addition, a positive effect of the vaccine was shown on average daily weight gain, number of antibiotic treatment days and percentage of animals marketed compared to controls.
Croatian: Nadalje, pozitivno djelovanje cjepiva dokazano je u prosječnom dnevnom povećanju tjelesne mase, broju dana terapijskog liječenja i postotka životinja u prometu u usporedbi s kontrolama.
English: In the future, if the animals are exposed to the bacteria, the immune system will be able to make antibodies more quickly.
Croatian: Ako životinje u budućnosti budu izložene tim infekcijama, imunosni sustav moći će brže reagirati.
English: Colibacillosis can cause injuries to the sac that surrounds the heart (pericarditis), the sac surrounding the liver (perihepatitis) and the ‘air sacs', the specialised bags within the bird's body where air is stored during breathing (airsacculitis), and can lead to death of the bird.
Croatian: Kolibaciloza može uzrokovati ozljede vrećice koja okružuje srce (perikarditis), vrećice koja okružuje jetru (perihepatitis), i „zračne vrećice”, specijalizirane vrećice unutar tijela ptice gdje su čuva zrak tijekom disanja (upala zračnih vrećica), što može dovesti do smrti životinje.
English: Poulvac E. coli, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Croatian: Kao i sva cjepiva, Poulvac E. coli djeluje „učeći” imunosni sustav (prirodnu obranu tijela) kako se obraniti protiv bolesti.
English: The withdrawal period for meat and eggs from chickens and turkeys treated with Poulvac E. coli is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso i jaja pilića i purana liječenih VMP-om Poulvac E. coli iznosi „nula” dana, drugim riječima nema obaveznog razdoblja čekanja.
English: This is a summary of the European Public Assessment Report (EPAR) for Poulvac E. coli.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za Poulvac E. coli.
English: Poulvac E. coli is available as a freeze dried powder (lyophilisate) which can be made into a suspension.
Croatian: Poulvac E. coli je dostupan kao smrznuti osušeni prašak (liofilizat) koji se koristi za pripremu suspenzije.
English: The use of eye-protection, gloves and a nose-mouth mask by the operator is recommended during administration.
Croatian: Preporuča se upotreba zaštite za oči, rukavica i maske za lice za osobu koja provodi cijepljenje.
English: It may also be present in faeces for up to five weeks post vaccination in chickens or seven days post vaccination in turkeys, and remain present in the environment until the end of the finishing (time to slaughter) or rearing period for chickens or for seven days for turkeys.
Croatian: Također može biti prisutan u stolici pilića do pet tjedana nakon cijepljenja ili do sedam dana nakon cijepljenja purana te ostati prisutan u okruženju do završetka (vremena klanja) ili razdoblja nesenja u pilića, odnosno sedam dana u purana.
English: Poulvac E. coli contains small amounts of the bacterium E. coli serotype O78.
Croatian: Poulvac E. coli sadrži male količine bakterije E. coli, serotip O78.
English: The vaccine strain can be detected in tissues (liver and heart) for up to six days after vaccination in chickens or in tissues (air sacs) for up to four days after vaccination in turkeys.
Croatian: Sojevi virusa mogu se naći u tkivima (jetra i srce) pilića do šest dana nakon cijepljenja ili u tkivima (zračnim vrećicama) purana do četiri dana nakon cijepljenja.
English: Therefore, it is recommended to clean and disinfect bird houses where the vaccine was administered after completion of the finishing or rearing period.
Croatian: Stoga se preporuča da se kokošinjci očiste i dezinficiraju u slučaju kada se cjepivo primjenjuje po završetku razdoblja klanja ili nesenja.
English: The studies also demonstrated that the vaccine provides chickens with eight weeks protection against colibacillosis lesions and 12 weeks protection against mortality from colibacillosis with spray vaccination and 12 weeks protection against lesions and mortality with drinking water vaccination.
Croatian: Ispitivanja su također pokazala da cjepivo može osigurati zaštitu pilića od 8 tjedana protiv kolibaciloznih lezija i imunizaciju od 12 tjedana protiv smrtnosti od kolibaciloze cijepljenjem putem spreja, te imunizaciju od 12 tjedana protiv lezija i smrtnosti cijepljenjem u vodi za piće.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Poulvac E. coli's benefits are greated that its risks and recommended that it be approved in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Poulvac E. coli nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: When Poulvac E. coli is given to a chicken or turkey, the animal's immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign' and makes antibodies against it.
Croatian: Nakon što se Poulvac E. coli primijeni na piliću ili puranu, imunosni sustav životinje prepoznaje dijelove bakterije sadržane u cjepivu kao „strano tijelo” te proizvodi protutijela protiv tih dijelova.
English: Laboratory studies showed that the vaccine is safe and that protection against colibacillosis lesions starts two weeks after vaccination in chickens and three weeks after vaccination in turkeys.
Croatian: Laboratorijskim je ispitivanjima utvrđeno da je cjepivo sigurno te da zaštita protiv kolibaciloznih lezija započinje dva tjedna nakon cijepljenja pilića i tri tjedna nakon cijepljenja purana.
English: In chickens it is given as a single dose either by coarse spray vaccination from one day of age or by adding to drinking water from five days of age.
Croatian: Pilićima se daje kao jednokratna doza masovnim cijepljenjem putem spreja pilića u starosti od jednog dana ili dodavanjem u vodu za piće pilića u dobi od pet dana.
English: What is Poulvac E. coli and what is it used for?
Croatian: Što je Poulvac E. coli i za što se koristi?
English: The birds consume the vaccine when preening their feathers.
Croatian: Perad konzumira cjepivo kljucanjem svog perja.
English: When adding Poulvac E. coli to drinking water a sufficient amount to supply one dose of reconstituted vaccine for every chicken should be added to as much water as is consumed by the chickens in three hours.
Croatian: Prilikom dodavanja Poulvac E. coli u vodu za piće treba dodati dovoljnu količinu kako bi se omogućila jedna doza rekonstituiranog cjepiva za svaku pticu tijekom tri sata.
English: For practical information about using Poulvac E. coli animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Poulvac E. coli vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Poulvac E. coli is a vaccine that is used in chickens and turkeys for active immunisation against an infection caused by Escherichia coli serotype O78 called colibacillosis.
Croatian: Poulvac E. coli je cjepivo koje se koristi u pilića i pura za aktivnu imunizaciju protiv infekcije uzrokovane bakterijom Escherichia coli, serotipom
English: When giving by coarse spray vaccination the reconstituted vaccine should be diluted and sprayed onto the birds so that each bird receives enough for one dose.
Croatian: Kad se primjenjuje masovnim cijepljenjem putem spreja, rekonstituirano se cjepivo treba razrijediti te poprskati životinje tako da svaka dobije količinu koja odgovara jednoj dozi.
English: In turkeys it is given by coarse spray vaccination from one day of age with a second dose three weeks later.
Croatian: Puranima se prva doza daje masovnim cijepljenjem putem spreja u starosti od jednog dana, a druga se doza daje tri tjedna kasnije.
English: What are the risks associated with Poulvac E. coli?
Croatian: Koji su rizici povezani s VMP-om Poulvac E. coli?
English: The full EPAR for Poulvac E. coli can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Poulvac E. coli nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Dodatne informacije o terapiji VMP-om Poulvac E. coli vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: It is also the time required after administration of a medicine before eggs 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 ili jaja dotične životinje.
English: Why is Poulvac E. coli approved?
Croatian: Zašto je Poulvac E. coli odobren?
English: Other information about Poulvac E. coli:
Croatian: Ostale informacije o VMP-u Poulvac E. coli
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Poulvac E. coli on 15 June 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Poulvac E. coli na snazi u Europskoj uniji od 15. lipnja 2012. Informacije o tome je li za ovaj proizvod potreban recept možete naći na etiketi/vanjskom dijelu pakiranja.
English: What benefits of Poulvac E. coli have been shown in the studies?
Croatian: Koje su koristi VMP-a Poulvac E. coli utvrđene u ispitivanjima?
English: How does Poulvac E. coli work?
Croatian: Kako djeluje Poulvac E. coli?
English: How is Poulvac E. coli used?
Croatian: Kako se koristi Poulvac E. coli?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/16/1139/001 OCALIVA
Croatian: Farmaceutski oblik Put primjene
English: It is given every 8 hours and the duration of treatment depends on the type of infection and its severity.
Croatian: Primjenjuje se svakih osam sati, a trajanje liječenja ovisi o vrsti i ozbiljnosti infekcije.
English: Further information on Vabomere can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Vabomere.
Croatian: Više informacija o lijeku Vabomere nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Vabomere.
English: Meropenem has been authorised in the EU since the 1990s.
Croatian: Meropenem je dostupan u Europskoj uniji (EU) od 1990.-ih.
English: Vabomere (meropenem / vaborbactam)
Croatian: Vabomere (meropenem / vaborbaktam)
English: It can also be used for infections caused by Gram-negative bacteria when other treatments might not work.
Croatian: Možete se upotrijebiti i za infekcije uzrokovane gram-negativnim bakterijama ako druga liječenja nisu dala rezultata.
English: What measures are being taken to ensure the safe and effective use of Vabomere?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vabomere?
English: What is Vabomere and what is it used for?
Croatian: Što je Vabomere i za što se primjenjuje?
English: Vabomere was compared with the doctor's choice of the best available antibiotic treatment.
Croatian: Lijek Vabomere uspoređen je s liječnikovim izborom najboljeg dostupnog antibiotskog liječenja.
English: Side effects reported with Vabomere are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Vabomere pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other information about Vabomere
Croatian: Ostale informacije o lijeku Vabomere
English: Vabomere is given by infusion (drip) into a vein over 3 hours.
Croatian: Vabomere se primjenjuje intravenskom infuzijom (nakapavanjem) u trajanju od tri sata.
English: Vabomere was found effective at treating infections in two studies.
Croatian: Lijek Vabomere pokazao se učinkovitim u liječenju infekcija u dvama ispitivanjima.
English: Why is Vabomere authorised in the EU?
Croatian: Zašto je Vabomere odobren u EU-u?
English: Fewer patients treated with Vabomere (14%) died within 4 weeks compared with those receiving best available antibiotic treatment (26%).
Croatian: Manji broj bolesnika liječenih lijekom Vabomere (14 %) preminuo je u roku od četiri tjedna u usporedbi s bolesnicima koji su primali najbolje dostupno antibiotsko liječenje (26 %).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vabomere 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 lijeka Vabomere nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The European Medicines Agency noted that there were limited options for treating infections with bacteria that carry beta-lactamases.
Croatian: Europska agencija za lijekove napomenula je da postoje ograničene opcije za liječenje infekcija bakterijama koje nose beta-laktamaze.
English: Tests for bacteria in the urine found that 67% (128 out of 192) of patients treated with Vabomere were cured, compared with 58% (105 out of 182) of patients treated with piperacillin and tazobactam.
Croatian: Pretragama na bakterije u mokraći utvrđeno je da je 67 % bolesnika (128 od 192) liječenih lijekom Vabomere izliječeno u usporedbi s 58 % bolesnika (105 od 182) liječenih piperacilinom i tazobaktamom.
English: Vabomere is an antibiotic used in adults to treat the following infections, including when they have spread into the blood (bacteraemia):
Croatian: Vabomere je antibiotik koji se primjenjuje u odraslih osoba za liječenje infekcija navedenih u nastavku, uključujući i infekcije koje su se proširile u krv (bakterijemija):
English: What are the risks associated with Vabomere?
Croatian: Koji su rizici povezani s lijekom Vabomere?
English: As for all medicines, data on the use of Vabomere are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Vabomere kontinuirano se prate.
English: • complicated abdominal infections of the tissues and organs in the belly (intra-abdominal infections);
Croatian: • kompliciranih trbušnih infekcija tkiva i organa u trbuhu (intraabdominalne infekcije)
English: The active substances in Vabomere, meropenem and vaborbactam, work in different ways.
Croatian: Djelatne tvari u lijeku Vabomere, meropenem i vaborbaktam, djeluju na različite načine.
English: For more information about using Vabomere, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Vabomere pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: By blocking the action of these enzymes, vaborbactam allows meropenem to act against bacteria that would otherwise be resistant to it.
Croatian: Onemogućavanjem djelovanja tih enzima, vaborbaktam omogućuje meropenemu da djeluje protiv bakterije koja bi, u suprotnom, bila otporna na njega.