FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to a paucity of data regarding the potential effects of other classes of medication prescribed for COPD, no conclusions could be drawn regarding the influence of concomitant medications on the risk of pneumonia in COPD patients.
Croatian: Zbog manjka podataka u vezi s potencijalnim učincima drugih razreda lijekova koji se propisuju za KOPB, nije bilo moguće izvući zaključke o utjecaju istodobno korištenih lijekova na rizik od pneumonije kod pacijenata s KOPB-om.
English: Since then other products containing ICS have been subject to review and it was considered that data on the risk of pneumonia with these products in the COPD population should be reviewed all together, so that the risk of pneumonia in this patient population could be further characterised.
Croatian: Otada su drugi lijekovi koji sadrže ICS postali predmetom revizija i smatra se da podatke o rizicima od pneumonije povezane s upotrebom tih lijekova u liječenju populacije pacijenata s KOPB-om treba u cijelosti revidirati, kako bi se rizik od pneumonije u toj populaciji pacijenata mogao dodatno precizirati.
English: It was acknowledged that any risk of pneumonia with ICS should be considered in context, as pneumonia is an intrinsic comorbidity to COPD with certain predisposing factors making some COPD patients more susceptible to this risk than others.
Croatian: Potvrđeno je da se rizik od pneumonije kod ICS-a treba razmatrati u kontekstu, s obzirom na to da je pneumonija intrinzični komorbiditet KOPB-a s određenim predispozicijskim čimbenicima koji pacijente s KOPB-om čine podložnijima tom riziku od drugih.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for ICS-containing medicinal products indicated in the treatment of COPD.
Croatian: Odbor je, slijedom toga, preporučio izmjene uvjeta za odobrenje za stavljanje u promet lijekova koji sadržavaju ICS indiciranih u liječenju KOPB-a.
English: Finally, the PRAC considered the ICS dose-response effect or the influence of LABA and other concomitant medications on the risk of pneumonia in COPD patients.
Croatian: Naposljetku, PRAC je razmotrio učinak s obzirom na reakcije na dozu ICS-a ili utjecaj LABA i drugih istodobno korištenih lijekova na rizik od pneumonije kod pacijenata s KOPB-om.
English: The PRAC therefore concluded that pneumonia (in COPD patients) should be added as a common adverse drug reaction in the product information of all ICS-containing products and that for products with an existing Risk Management Plan, “increased risk of pneumonia in COPD patients” should be considered an Important Identified Risk.
Croatian: PRAC je stoga zaključio da se pneumonija (kod pacijenata s KOPB-om) treba navesti pod uobičajene nuspojave lijeka u informacijama o svim lijekovima koji sadrže ICS i da se za lijekove s postojećim planom upravljanja rizikom „povećan rizik od pneumonije kod pacijenata s KOPB-om” treba smatrati važnim utvrđenim rizikom.
English: To mitigate the risk of pneumonia, the PRAC considered that a warning should be included in the product information for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD.
Croatian: Kako bi se ublažio rizik od pneumonije, PRAC je zaključio da je u informacije o proizvodu potrebno uključiti upozorenje za zdravstvene radnike i pacijente kako bi bili na oprezu u pogledu mogućeg razvoja pneumonije kod pacijenata s KOPB-om, uzimajući u obzir podudaranje simptoma pneumonije s onima egzacerbacije KOPB-.
English: • The PRAC concluded that the evidence provided supports a causal association between the use of ICS-containing products and an increased risk of pneumonia in COPD patients;
Croatian: • PRAC je zaključio da dokazi podupiru uzročnu povezanost između upotrebe lijekova koji sadrže ICS i povećanog rizika od pneumonije kod pacijenata s KOPB-om;
English: • The PRAC was of the view that the increased risk of pneumonia should be included in the product information of all ICS-containing products indicated in the treatment of COPD, with a warning for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD.
Croatian: • PRAC je zaključio da je povećan rizik od pneumonije potrebno uključiti u informacije o proizvodu svih lijekova koji sadrže ICS indiciranih u liječenju KOPB-a, s upozorenjem za zdravstvene radnike i pacijente da budu na oprezu u pogledu mogućeg razvoja pneumonije kod pacijenata s KOPB-om, uzimajući u obzir podudaranje simptoma pneumonije s onima egzacerbacije KOPB-a.
English: • The PRAC reviewed the data submitted by the marketing authorisation holders in relation to the increased risk of pneumonia in patients with COPD in association with ICS-containing medicinal products;
Croatian: • PRAC je revidirao podatke koje su dostavili nositelji odobrenja za stavljanje lijeka u promet povezne s povećanim rizikom od pneumonije kod pacijenata s KOPB-om u vezi s lijekovima koji sadrže inhalacijske kortikosteroide;
English: Exacerbations and comorbidities contribute to the overall severity in individual patients [Global Initiative for Obstructive Lung Disease (GOLD), 2015].
Croatian: Egzacerbacije i komorbiditeti doprinose ukupnoj ozbiljnosti pojedinih pacijenata [Globalna inicijativa za kroničnu opstruktivnu plućnu bolest (GOLD), 2015.]. Simptomi KOPB-a uključuju dispneju, kronični kašalj i kronično stvaranje sputuma.
English: In conclusion, the PRAC considered that the benefit-risk balance of ICS-containing products remained favourable, provided the proposed changes to the product information are implemented.
Croatian: Naposljetku, PRAC je zaključio da je omjer koristi i rizika kod lijekova koji sadrže ICS i dalje povoljan, pod uvjetom da se provedu predložene promjene u informacijama o lijeku.
English: In view of the above, the Committee considers that the benefit-risk balance of ICS-containing medicinal products remains favourable in the treatment of COPD subject to the agreed amendments to the product information.
Croatian: Odbor je zaključio da je omjer koristi i rizika lijekova koji sadrže ICS i dalje povoljan u liječenju KOPB-a pod uvjetom da se provedu dogovorene izmjene u informacijama o lijeku.
English: When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.
Croatian: Kada se izloži bilo kojem od tih virusa kasnije u životu, mačka se ili neće zaraziti ili će imati puno manje ozbiljnu infekciju.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Croatian: Ubuduće će imunosni sustav moći brže proizvoditi protutijela ako je ponovno izložen virusima.
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Croatian: Ako trebate više informacija o zdravstvenom stanju ili liječenje svoje životinje, obratite se svojem veterinaru.
English: The studies included young and adult cats of various breeds, but not young kittens.
Croatian: Ispitivanja su uključivala mlade i odrasle mačke različitih pasmina, ali ne i mačiće.
English: It can also prevent death due to panleucopenia.
Croatian: Također može spriječiti uginuće životinje zbog panleukopenije.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every three years.
Croatian: Mačku treba ponovno cijepiti za sve bolesti godinu dana nakon prvog cijepljenja, a potom svake tri godine.
English: The first injection should be given in kittens aged at least eight weeks, with a second injection three to four weeks later.
Croatian: Prvu injekciju treba dati mačićima u dobi od najmanje 8 tjedana, a drugu injekciju tri ili četiri tjedna kasnije.
English: When a cat is given the vaccine, the immune system recognises the weakened or killed viruses as ‘foreign' and makes antibodies against them.
Croatian: Kad mačka primi cjepivo, imunosni sustav prepoznaje oslabljene ili ubijene viruse kao „strano tijelo” i proizvodi protutijela na njih.
English: Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Croatian: Povremeno će mačke razviti privremenu apatiju (gubitak interesa za okolinu) i anoreksiju (gubitak apetita) kao i hipertermiju (povišenu tjelesnu temperaturu) koja traje dan ili dva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCP on 23 February 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje VMP-a Purevax RCP u promet koje je na snazi u Europskoj uniji od 23. veljače 2005.
English: Purevax RCP should not be used in pregnant cats.
Croatian: Purevax RCP ne smije se primjenjivati u gravidnih mačaka.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCP exceed the risks for the approved indications and recommended that Purevax RCP be given a marketing authorisation.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi cjepiva Purevax RCP premašuju rizike za odobrene indikacije i preporučio je izdavanje odobrenja za stavljanje u promet cjepiva Purevax RCPCh.
English: The main measure of effectiveness was the level of antibodies in the blood against the viruses in the vaccine.
Croatian: Glavna mjera učinkovitosti bila je koncentracija protutijela u krvi naspram virusa u cjepivu.
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
Croatian: • inaktivirane (mrtve) antigene kaliciviroze (sojeve FCV 431 i G1),
English: In the field, the studies of Purevax RCP looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
Croatian: Na terenu, ispitivanja cjepiva Purevax RCP fokusirala su se na temeljni raspored cijepljenja (2 injekcije u razmaku od 3 do 4 tjedna) te na docjepljivanje (samo jedna injekcija).
English: In laboratory conditions Purevax RCP was demonstrated to provide protection against the diseases listed above.
Croatian: U laboratorijskim uvjetima je dokazano da Purevax RCP osigurava zaštitu protiv prethodno spomenutih bolesti.
English: Purevax RCP is used to vaccinate cats from the age of 8 weeks against:
Croatian: Purevax RCP se koristi za cijepljenje mačaka u dobi od 8 tjedana nadalje:
English: The antibodies will help to protect against the diseases caused by these viruses.
Croatian: To pomaže u zaštiti od bolesti koje uzrokuju virusi.
English: Purevax RCP is a veterinary vaccine that contains:
Croatian: Purevax RCP je veterinarsko cjepivo koje sadrži:
English: • attenuated feline panleucopenia virus (PLI IV).
Croatian: • oslabljenog virusa mačje panleukopenije (PLI IV).
English: The effectiveness of Purevax RCP has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or parvovirus.
Croatian: Učinkovitost cjepiva Purevax RCP ispitana je u nekoliko ispitivanja u laboratorijskim uvjetima gdje su mačke cijepljene i inficirane virulentnim herpesvirusom, kalicivirusom ili parvovirusom.
English: Purevax RCP contains small amounts of weakened or killed viruses that cause feline rhinotracheitis, calicivirosis and panleucopenia.
Croatian: Purevax RCP sadrži male količine oslabljenih ili mrtvih virusa i bakterija koji uzrokuju mačji rinotraheitis, kalicivirozu i panleukopeniju.
English: Purevax RCP is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Croatian: Cjepivo RCP FeLV dostupno je kao liofilizat (peleta osušena smrzavanjem) i otapalo koji služe za pripremu suspenzije za injekciju.
English: Information on the prescription status of this product may be found on the label/outer package.
Croatian: Informacije o tome je li za ovaj VMP potreban veterinarski recept možete naći na etiketi/vanjskom pakiranju.
English: Other information about Purevax RCP:
Croatian: Ostale informacije o VMP-u Purevax RCP:
English: Purevax RCP is a vaccine.
Croatian: Purevax RCP je cjepivo.
English: What benefit has Purevax RCP shown during the studies?
Croatian: Koje je koristi Purevax RCP pokazao tijekom ispitivanja?
English: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
Croatian: • atenuirani (oslabljeni) herpesvirus mačjeg rinotraheitisa (soj FHV F2),
English: What is the risk associated with Purevax RCP?
Croatian: Koji su rizici povezani s cjepivom Purevax RCP?
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
Croatian: U terenskom istraživanju temeljnog cijepljenja postojao je porast u protutijelima protiv mačjeg herpesvirusa rinotraheitisa, infekcije kalicivirusom te virusa panleukopenije.
English: • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus).
Croatian: • mačje panleukopenije (ozbiljne bolesti koja uzrokuje krvavi proljev uzrokovan parvovirusom),
English: Why has Purevax RCP been approved?
Croatian: Zašto je VMP Purevax RCP odobren?
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and feline panleucopenia remained stable at a high level or increased slightly.
Croatian: U ispitivanju koje je ispitivalo docjepljivanje, razine protutijela na herpesvirus rinotraheitisa, infekciju kalicivirusom i mačju leukopeniju ostale su stabilne pri visokim razinama ili su blago povećane.
English: Feline viral rhinotracheitis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine
Croatian: Cjepivo protiv mačjeg rinotraheitisa, mačje panleukopenije (živo oslabljeno) i mačje kaliciviroze (inaktivirano)
English: • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
Croatian: • mačje kaliciviroze (bolesti nalik gripi s upalom usne šupljine koju uzrokuje kalicivirus).
English: What is Purevax RCP?
Croatian: Što je Purevax RCP?
English: For a full list of the side-effects reported with Purevax RCP, see the package leaflet.
Croatian: Potpuni popis svih nuspojava pri primjeni VMP-a Purevax RCP potražite u uputi o VMP-u.
English: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
Croatian: • mačjeg virusnog rinotraheitisa (bolesti nalik gripi koju uzrokuje herpesvirus).
English: How does Purevax RCP work?
Croatian: Kako djeluje Purevax RCP?
English: What is Purevax RCP used for?
Croatian: Za što se koristi Purevax RCP FeLV?
English: How has Purevax RCP been studied?
Croatian: Kako je VMP Purevax RCP ispitivan?
English: It is available as tablets (30 mg).
Croatian: Dostupan je kao tablete (30 mg).
English: This summary was last updated in 12-2014.
Croatian: Ovaj sažetak je posljednji put ažuriran u 12. 2014.
English: EllaOne can be taken at any time during the menstrual cycle.
Croatian: EllaOne se smije uzeti bilo kada tijekom menstruacijskog ciklusa.
English: Of the women who completed the main study, 2.1% (26 out of 1,241) became pregnant.
Croatian: U slučaju žena koje su završile glavno ispitivanje, zatrudnjelo je 2,1 % (26 od 1 241).
English: If ovulation has already occurred, ellaOne is no longer effective.
Croatian: Ako je ovulacija već nastupila, ellaOne više nije djelotvoran.
English: The full EPAR for ellaOne can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek ellaOne nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was the number of women who did not become pregnant.
Croatian: Glavna mjera djelotvornosti bio je broj žena koje nisu zatrudnjele.
English: This is less than the 5.5% of women who would have been expected to become pregnant if they had not taken any contraceptive.
Croatian: To predstavlja manje od 5,5 % žena za koje se očekivalo da će zatrudnjeti ako ne uzmu bilo kakvo kontracepcijsko sredstvo.
English: EllaOne therefore prevented about three-fifths of the pregnancies.
Croatian: EllaOne je stoga spriječio otprilike tri petine ukupnog broja trudnoća.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ellaOne on 15 May 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek ellaOne na snazi u Europskoj uniji od 15. svibnja 2009.
English: If the woman vomits within three hours of taking the medicine she should take another tablet.
Croatian: Javi li se u žene povraćanje unutar 3 sata nakon uzimanja lijeka, treba uzeti još jednu tabletu.
English: This number was calculated from published pregnancy rates.
Croatian: Ovaj je broj izračunat na temelju objavljenih stopa trudnoće.
English: An additional study compared ellaOne with levonorgestrel (another medicine used in emergency contraception).
Croatian: Dodatno ispitivanje usporedilo je ellaOne s levonorgestrelom (drugim lijekom koji se koristi kao hitna kontracepcija).
English: EllaOne was effective as an emergency contraceptive, reducing the number of unintended pregnancies.
Croatian: EllaOne je učinkovit kao hitna kontracepcija, u smanjivanju broja neželjenih trudnoća.
English: Other information about ellaOne:
Croatian: Ostale informacije o lijeku ellaOne:
English: The medicine can be obtained without a prescription.
Croatian: Lijek se izdaje samo na liječnički recept.
English: If a woman's menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before ellaOne is taken.
Croatian: Ako ženi kasni menstruacija ili u slučaju simptoma trudnoće, prije primjene ellaOne potrebno je isključiti trudnoću.
English: What measures are being taken to ensure the safe and effective use of ellaOne?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka ellaOne?
English: This means that it attaches to the receptors that progesterone normally attaches to, preventing the hormone from having its effect.
Croatian: To znači da se vezuje na receptore na koje se normalno vezuje progesteron sprječavajući djelovanje hormona.
English: EPAR summary for the public ellaOne ulipristal acetate
Croatian: EPAR, sažetak za javnost ellaOne ulipristal acetat
English: Through its actions on the progesterone receptors, ellaOne prevents pregnancies mainly by preventing or delaying ovulation.
Croatian: Svojim djelovanjem na receptore progesterona, ellaOne sprječava trudnoću uglavnom sprječavajući ili odgađajući ovulaciju.
English: For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of the egg (fusion with a sperm) and implantation in the womb.
Croatian: Da bi došlo do trudnoće, mora nastupiti ovulacija (otpuštanje jajašca) nakon čega slijedi oplodnja jajašca (spajanje sa spermom) i ugnježđenje u maternicu.
English: This number was then compared with the number of women who would have been expected to become pregnant if they had not taken a contraceptive.
Croatian: Ovaj je broj uspoređen s brojem žena za koje se očekivalo da će zatrudnjeti u slučaju da nisu uzele kontracepcijsko sredstvo.
English: In one main study, ellaOne was given to 1,533 women (aged on average 24 years) who had requested emergency contraception between two and five days after unprotected sex or contraceptive failure.
Croatian: U jednom glavnom ispitivanju, ellaOne je primijenjen u 1.533 žena (prosječne dobi od 24 godine starosti) koje su zatražile hitnu kontracepciju unutar dva do pet dana nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ellaOne.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet, te preporuke o uvjetima uporabe za lijek ellaOne.
English: For more information about treatment with ellaOne, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom ellaOne pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: EllaOne is taken as one tablet by mouth as soon as possible, but no later than 120 hours, after unprotected sex or contraceptive failure.
Croatian: EllaOne se uzima kao jedna tableta na usta što je prije moguće, ali ne kasnije od 120 sati nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode.
English: For the full list of all side effects and restrictions, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja potražite u uputi o lijeku.
English: The most common side effects with ellaOne are headache, nausea (feeling sick), abdominal pain (stomach ache) and dysmenorrhea (period pains).
Croatian: Najčešće nuspojave lijeka ellaOne su glavobolja, mučnina (osjećaj slabosti), abdominalna bol (bol u trbuhu) i dismenoreja (menstruacijski bolovi).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ellaOne, 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 ellaOne nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: A risk management plan has been developed to ensure that ellaOne is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka ellaOne.
English: What is the risk associated with ellaOne?
Croatian: Koji su rizici povezani s lijekom ellaOne?
English: What is ellaOne?
Croatian: Što je ellaOne?
English: This document is a summary of the European public assessment report (EPAR) for ellaOne.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku ellaOne.
English: The CHMP decided that ellaOne's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP odlučio je da koristi od lijeka ellaOne nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: EllaOne is a medicine that contains the active substance ulipristal acetate.
Croatian: EllaOne je lijek koji sadrži djelatnu tvar ulipristal acetat.
English: Why has ellaOne been approved?
Croatian: Zašto je ellaOne odobren?
English: In this study, ellaOne was as effective as levonorgestrel at preventing pregnancies.
Croatian: U ovom ispitivanju ellaOne bio je podjednako djelotvoran kao levonorgestrel u sprječavanju trudnoća.
English: The sex hormone progesterone plays a role in the timing of ovulation and in preparing the lining of womb to receive the fertilised egg.
Croatian: Spolni hormon progesteron igra značajnu ulogu u određivanju trenutka ovulacije te u pripremi ovojnice maternice za primitak oplođenog jajašca.
English: The active substance in ellaOne, ulipristal acetate, acts as a progesterone receptor modulator.
Croatian: Djelatna tvar lijeka ellaOne, ulipristal acetat, djeluje kao modulator receptora progesterona.
English: The additional study, which included women who took the medicine within two days of unprotected sex or contraceptive failure, supported the effectiveness of ellaOne.
Croatian: Dodatno ispitivanje, koje je obuhvatilo žene koje su uzele lijek unutar dva dana nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode, potvrdilo je djelotvornost lijeka ellaOne.