FrancophonIA/ELRC3.0 huggingface dataset:
English: The HMPC noted the lack of clinical studies on the effects of caraway fruit in patients, but took into account the well documented use of this herbal medicine for the above-mentioned use.
Croatian: HMPC je istaknuo nedostatak kliničkih ispitivanja s kimovim plodom, no uzeo je u obzir dobro dokumentiranu primjenu ovog biljnog lijeka za prethodno navedene primjene.
English: Any applications for the licensing of medicines containing caraway fruit have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže kimov plod moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: The HMPC conclusions on the use of caraway fruit medicines for the relief of digestive problems such as bloating and flatulence are based on their ‘traditional use' in this condition.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže kimov plod za ublažavanje probavnih problema poput nadutosti i vjetrova temelje se na „tradicionalnoj uporabi” kod tih stanja.
English: Further information on the HMPC assessment of caraway fruit medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže kimov plod, uključujući pojedinosti zaključaka Povjerenstva, nalaze se u dokumentu u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with caraway fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže kimov plod, uključujući odgovarajuće mjere opreza za sigurnu uporabu, nalazi se u monografiji u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC concluded that, on the basis of its long-standing use, caraway fruit medicines can be used for the relief of problems of the digestive system such as bloating and flatulence.
Croatian: HMPC je zaključio da se, na temelju njegove dugotrajne uporabe, lijekovi koji sadrže kimov plod mogu koristiti za ublažavanje problema probavnog sustava poput nadutosti i vjetrova.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing caraway fruit.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže kimov plod.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of caraway fruit.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe kimovog ploda.
English: Detailed instructions on how to take caraway fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o načinu primjene lijekova koji sadrže kimov plod kao i o tome tko ih može koristiti navedene su u uputi o lijeku priloženoj uz lijek.
English: Other information about caraway fruit medicines
Croatian: Ostale informacije o lijekovima koji sadrže kimov plod
English: What are the risks associated with caraway fruit medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže kimov plod?
English: For more information about treatment with caraway fruit medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže kimov plod pročitajte u uputi o lijeku priloženoj uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using caraway fruit medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže kimov plod bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Caraway fruit
Croatian: Kimov plod
English: What evidence supports the use of caraway fruit medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže kimov plod?
English: How are caraway fruit medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže kimov plod?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: dokazi o njihovoj sigurnoj primjeni na opisani način najmanje 30 godina (uključujući najmanje 15 godina na području EU).
English: 20 October 2015 EMA/498568/2015
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20. listopada 2015. EMA/498568/2015
English: Caraway fruit is the common name for the fruit of the plant Carum carvi L. The plant is cultivated or gathered to obtain the fruit for medicinal use.
Croatian: Kimov plod je uobičajen naziv za plod biljke Carum carvi L.
English: Equine influenza is a highly contagious disease that is very common in horses but rarely causes death.
Croatian: Influenca konja je visoko zarazna bolest koja je vrlo česta u konja, ali rijetko uzrokuje smrt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ProteqFlu on 6 March 2003.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod ProteqFlu dana 6. ožujka 2003.
English: Other information about ProteqFlu:
Croatian: Druge informacije o ProteqFlu:
English: Horses should receive a primary vaccination, consisting of two injections at 5-6 months of age, given 4-6 weeks apart.
Croatian: Konji trebaju primiti primarno cijepljenje koje se sastoji od dvije injekcije u dobi od 5 do 6 mjeseci, a daju se u razmaku od 4 do 6 tjedana.
English: In case of increased risk of infection or insufficient intake of colostrum (first milk), an additional initial injection can be given at the age of 4 months, followed by the full vaccination programme (primary vaccination and following revaccinations).
Croatian: U slučaju povećanog rizika ili nedostatnog uzimanja kolostruma (prvog mlijeka), može se dati dodatna injekcija ProteqFlu-Te u dobi od 4 mjeseca nakon čega slijedi program potpunog cijepljenja (prvo cijepljenje i ponovna cijepljenja).
English: The withdrawal period for ProteqFlu for meat and milk is zero days.
Croatian: Karencija za ProteqFlu za meso i mlijeko iznosi nula dana.
English: This means that a gene from two different equine influenza strains (A/eq/Ohio/03 and A/eq/Richmond/1/07) was inserted into the canarypox vector viruses, which do not produce disease in horses, allowing the vector to produce specific proteins from these influenza strains.
Croatian: To znači da je gen dva različita virusa influence konja (A/eq/Ohio/03 i A/eq/Richmond/1/07) umetnut u virusne vektore virusa boginja kanarinca koji ne uzrokuju bolest u konja omogućavajući vektoru da proizvede specifične proteine različite od sojeva influence.
English: The effectiveness of ProteqFlu was first assessed in several laboratory and field studies.
Croatian: Djelotvornost cjepiva ProteqFlu procijenjena je prvo u nekoliko laboratorija i terenskih ispitivanja.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Croatian: Ako želite više informacija na temelju preporuka Odbora za veterinarsko-medicinske proizvode (CVMP), pročitajte znanstvenu raspravu (ista je dio Europskoga javnog izvješća o procjeni veterinarskomedicinskog proizvoda (EPAR)).
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Croatian: Cjepiva djeluju „učenjem” imunološki sustava (prirodnog obrambenog mehanizma) kako se obraniti od bolesti.
English: A short lived swelling at the injection site may occur (max. diameter 5 cm) which decreases within 4 days.
Croatian: Može se pojaviti kratkotrajno oticanje na mjestu injekcije (maksimalnog promjera 5 cm) koje se smanjuje unutar 4 dana.
English: The immunogenicity of the current formulation of the vaccine was confirmed in 15 foals.
Croatian: Imunogenost trenutne formulacije cjepiva potvrđena je na 15 ždrebadi.
English: The duration of protection was 5 months after primary vaccination and one year after the third vaccination.
Croatian: Zaštita je trajala 5 mjeseci nakon prvog cijepljenja i godinu dana nakon trećeg cijepljenja.
English: The immune system will then be able to make those protective antibodies more quickly when the animal is naturally exposed to the equine flu viruses.
Croatian: Imunološki će sustav potom moći brže proizvesti ta zaštitna protutijela kad je životinja prirodno izložena virusima influence konja.
English: The vaccine is given as an intramuscular injection (injection into a muscle).
Croatian: Cjepivo se daje u obliku intramuskularne injekcije (injekcija u mišić).
English: ProteqFlu contains an adjuvant (carbomer) to enhance the immune response.
Croatian: ProteqFlu sadrži adjuvans (karbomer) za jačanje imunološke reakcije.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Croatian: U slučaju nehotičnog samoinjektiranja potrebno je odmah potražiti savjet liječnika i pokazati liječniku Uputu o proizvodu i etiketu.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu exceed the risks for the approved indication and recommended that ProteqFlu be given a marketing authorisation.
Croatian: Povjerenstvo za veterinarsko-medicinske proizvode (CVMP) zaključilo je da koristi cjepiva ProteqFlu premašuju rizike za odobrene indikacije i preporučilo izdavanje odobrenja za stavljanje u promet za ProteqFlu.
English: ProteqFlu is available as a suspension for injection.
Croatian: ProteqFlu je dostupan kao suspenzija za injekciju.
English: ProteqFlu is a vaccine which was produced with the use of recombinant DNA technology.
Croatian: ProteqFlu je cjepivo proizvedeno uporabom tehnologije rekombinantne DNK.
English: In laboratory studies, horses were challenged (infected) with equine influenza virus and the clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non-vaccinated animals or those vaccinated with a competitor product).
Croatian: U laboratorijskim ispitivanjima konji su testirani (zaraženi) virusom influence konja, a klinički znakovi i izlučivanje virusa influence nakon zaraze uspoređeni su između cijepljenih i kontrolnih životinja (necijepljene životinje ili one cijepljene konkurentnim proizvodom).
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption.
Croatian: Karencija je razdoblje dozvoljeno nakon primjene lijeka prije nego što se se životinja smije zaklati, a njezino meso ili mlijeko koristiti za ljudsku prehranu.
English: What is ProteqFlu?
Croatian: Što je ProteqFlu?
English: ProteqFlu is a vaccine for use in horses.
Croatian: ProteqFlu je cjepivo za konje.
English: What is the risk associated with ProteqFlu?
Croatian: Koji su rizici povezani s ProteqFlu?
English: The current formulation of ProteqFlu produced similar antibody responses against the two flu strains included in the vaccine to those seen in the main studies.
Croatian: Trenutna formulacija cjepiva ProteqFlu proizvela odgovore protutijela protiv dva soja virusa influence uključenih u cjepivo slične onima uočenim u glavnom ispitivanju.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika može se naći u modulu sa znanstvenim raspravama ovog EPAR-a.
English: The measure of effectiveness in all studies was antibody levels against the two influenza vaccine strains.
Croatian: Mjera djelotvornosti u svim ispitivanjima bila je razina protutijela uspoređena s dva soja virusa influence.
English: Why has ProteqFlu been approved?
Croatian: Zašto je ProteqFlu odobren?
English: The studies showed that ProteqFlu was effective in reducing clinical signs and virus excretion after infection with equine influenza, 14 days after primary vaccination.
Croatian: Ispitivanja su pokazala da je ProteqFlu djelotvoran u redukciji kliničkih znakova i ekskreciji virusa nakon infekcije influencom konja 14 dana nakon prvog cijepljenja.
English: Most of the studies were performed with ProteqFlu-Te, a vaccine that protects against two strains of equine influenza as well as against tetanus.
Croatian: Veći broj ispitivanja proveden je koristeći cjepivo ProteqFlu-Te koje štiti protiv dva soja virusa influence konja kao i protiv tetanusa.
English: This will help to protect against equine influenza.
Croatian: To će pospješiti zaštitu protiv influence konja.
English: This should be followed by revaccination 5 months later and afterwards by yearly booster vaccinations.
Croatian: Ponovno cijepljenje treba uslijediti nakon 5 mjeseci i nakon toga godišnje docjepljivanje.
English: It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively.
Croatian: Sadrži dijelove dva soja konjskog virusa influence koji su umetnuti u dva vektor virusa boginja kanarinca (nositelj).
English: ProteqFlu is used to vaccinate horses from 4 months of age against equine influenza.
Croatian: ProteqFlu se koristi za cijepljenje konja starosti od 4 mjeseca, a protiv influence konja.
English: When ProteqFlu is given to horses, the animals' immune system recognises the specific proteins from the equine influenza strains as ‘foreign' and makes antibodies against them.
Croatian: Nakon što se ProteqFlu da konjima, imunološki sustav životinja prepoznaje specifične proteine sojeva influence konja i toksoid tetanusa kao „strana tijela” i proizvodi protutijela.
English: The vaccine reduces the clinical signs of equine influenza and the excretion (shedding) of the virus after infection.
Croatian: Cjepivo reducira kliničke znakove influence konja ekskreciju (izlučivanje) virusa nakon infekcije.
English: Equine influenza vaccine
Croatian: Cjepivo protiv influence konja
English: What benefit has ProteqFlu shown during the studies?
Croatian: Koje koristi ProteqFlu su utvrđene tijekom ispitivanja?
English: What is ProteqFlu used for?
Croatian: Za što se ProteqFlu koristi?
English: How has ProteqFlu been studied?
Croatian: Kako se ProteqFlu ispitivao?
English: There are two options:
Croatian: Dvije su mogućnosti:
English: Older than 36 years
Croatian: Starije od 36 godina
English: Dosing during the stimulation cycle
Croatian: Doziranje tijekom stimulacijskog ciklusa
English: The absolute bioavailability is 58% (48-70%
Croatian: Apsolutna bioraspoloživost je 58% (48-70%
English: Difference [95% CI]
Croatian: Razlika [95% CI]
English: 1) and is reached 44 hours (35-57 hours
Croatian: 1) i postiže se 44 sata (35-57 sati
English: - Wash your hands with soap and water and dry them before you use Elonva.
Croatian: - Operite ruke sapunom i vodom i osušite ih prije nego primijenite lijek Elonva.
English: The chance of having a side effect is described by the following categories:
Croatian: Vjerojatnost da razvijete neku nuspojavu opisana je sljedećim kategorijama:
English: See Table 1 below.
Croatian: Vidjeti tablicu 1 niže.
English: The eggs are collected from the ovary 34-36 hours later.
Croatian: Jajne stanice vade se iz jajnika 34-36 sati kasnije.
English: Do not throw away an empty or unused syringe via household waste.
Croatian: Nikada nemojte prazne ili nekorištene štrcaljke bacati u kućni otpad.
English: Always use Elonva exactly as your doctor has told you.
Croatian: Uvijek primijenite lijek Elonva točno onako kako Vam je rekao liječnik.
English: However, the differences were within the predefined equivalence (ENGAGE and ENSURE) or non-inferiority (PURSUE) margins.
Croatian: Međutim, razlike su se nalazile unutar unaprijed definiranih granica ekvivalencije (ENGAGE i ENSURE) ili neinferiornosti (PURSUE).
English: Your doctor will advise you at what time you can start performing pregnancy tests.
Croatian: Vaš liječnik će Vas savjetovati kada možete početi koristiti testove na trudnoću.
English: Predicted range for 90% of subjects.
Croatian: Predviđeni raspon za 90% ispitanica.
English: Therefore, close supervision by your doctor is very important.
Croatian: Stoga je vrlo važno da budete pod strogim nadzorom Vašeg liječnika.
English: The steady state volume of distribution is 9.2 L (6.5-13.1 L
Croatian: Volumen distribucije u stanju dinamičke ravnoteže iznosi 9,2 l (6,5-13,1 l
English: - if you notice that the syringe or the needle is damaged.
Croatian: ukoliko primijetite da je oštećena štrcaljka ili igla.
English:  Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
Croatian: • Abnormalno (nemenstrualno) vaginalno krvarenje bez poznatog/dijagnosticiranog uzroka.
English: What Elonva is and what it is used for
Croatian: Što je Elonva i za što se koristi
English: Gonadotropic hormones play an important role in human fertility and reproduction.
Croatian: Gonadotropni hormoni imaju važnu ulogu u ljudskoj plodnosti i reprodukciji.
English: Other medicines and Elonva
Croatian: Drugi lijekovi i Elonva
English: Less than 50 kg
Croatian: Manje od 50 kg
English: Date of first authorisation: 25 January 2010 Date of latest renewal: 22 August 2014
Croatian: Datum posljednje obnove odobrenja: 22. kolovoza 2014.
English: In case of a positive pregnancy test, contact your doctor.
Croatian: U slučaju pozitivnog rezultata testa na trudnoću, javite se Vašem liječniku.
English: Not studied.
Croatian: Nisu ispitane.
English: This is a serious medical condition where the ovaries are overly stimulated and the growing follicles become larger than normal.
Croatian: To je ozbiljno zdravstveno stanje u kojem su jajnici pretjerano stimulirani pa folikuli narastu veći nego što je normalno.
English: Because of the risk of developing OHSS, patients should be monitored for at least two weeks after hCG administration.
Croatian: Zbog rizika od razvoja OHSS-a, bolesnice treba pratiti najmanje dva tjedna nakon primjene hCG-a.
English:  Risk factors for OHSS:
Croatian: • Faktori rizika za OHSS:
English: Not known (cannot be estimated from available data) - Allergic reactions (hypersensitivity reactions, both local and generalised, including rash).
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka) alergijske reakcije (reakcije preosjetljivosti, lokalne i generalizirane, uključujući osip)
English: Do not use Elonva - if it has been stored out of the refrigerator for more than one month.
Croatian: Nemojte koristiti lijek Elonva ukoliko ste ga čuvali izvan hladnjaka dulje od mjesec dana.
English: In the absence of compatibility studies, the medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: Preclinical data revealed no special hazard for humans based on conventional studies of single and repeated dose toxicity and safety pharmacology.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti pojedinačne i ponovljenih doza i sigurnosne farmakologije.
English: In general, adequate follicular development is achieved on average by the ninth day of treatment (range 6 to 18 days).
Croatian: Općenito se adekvatni razvoj folikula u prosjeku postiže do devetog dana liječenja (raspon od 6. do 18. dana).
English: Your doctor may also check blood hormone levels.
Croatian: Liječnik Vam također može provjeriti razine hormona u krvi.
English: If you forgot to inject Elonva on the day you should have, contact your doctor immediately.
Croatian: Ako zaboravite injicirati lijek Elonva na dan kada ste trebali, odmah se javite svom liječniku.
English: Not recommended with a GnRH agonist protocol
Croatian: Ne preporučuje se uz protokol s agonistom GnRH
English: Corifollitropin alfa has an elimination half-life of 70 hours (59-82 hours
Croatian: Poluvrijeme eliminacije korifolitropina alfa iznosi 70 sati (59-82 sata
English: It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis.
Croatian: Međutim, treba znati da i sama trudnoća donosi povećan rizik od tromboze.
English: Elonva is intended for single subcutaneous injection only.
Croatian: Elonva je namijenjena samo za jednokratnu supkutanu injekciju.
English: <Justification for not including Braille accepted>
Croatian: <Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma>
English: Congenital malformations
Croatian: Kongenitalne malformacije
English: Both embryotoxicity and teratogenicity are considered a consequence of the superovulatory state of the animal not able to support a number of embryos above a physiological ceiling.
Croatian: Smatra se da su i embriotoksičnost i teratogenost posljedica superovulacijskog stanja u kojem životinja ne može podržati broj embrija iznad svoje fiziološke granice.
English: Corifollitropin alfa does not display any intrinsic LH/hCG activity.
Croatian: Korifolitropin alfa ne pokazuje intrinzičnu LH/hCG aktivnost.
English: Infertility evaluation before starting treatment
Croatian: Procjena neplodnosti prije početka liječenja
English: Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotropins, ATC code: G03GA09
Croatian: Farmakoterapijska skupina: spolni hormoni i modulatori reproduktivnog sustava, gonadotropini, ATK oznaka: G03GA09.
English: - Clean about 5 cm around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.
Croatian: - Očistite približno 5 cm oko točke u koju ćete ubosti iglu i ostavite dezinfekcijsko sredstvo da se osuši najmanje jednu minutu prije nego što nastavite s postupkom.
English: Treatment with the GnRH-antagonist usually starts 5 to 6 days after the injection of Elonva.
Croatian: Liječenje antagonistom GnRH-a obično počinje 5 do 6 dana nakon injekcije lijeka Elonva.
English: Women should be advised that if they feel dizzy, they should not drive or use machines.
Croatian: Ženama treba savjetovati da, ako osjete omaglicu, ne smiju upravljati vozilima niti raditi sa strojevima.
English: Stimulation day 5 or 6:
Croatian: 5. ili 6. dan stimulacije:
English: If OHSS develops, standard and appropriate management of OHSS should be implemented and followed.
Croatian: Ako se razvije OHSS, potrebno je primijeniti i pridržavati se standardnog i odgovarajućeg liječenja OHSS-a.
English: If you feel dizzy, you should not drive or use machines.
Croatian: Ako osjetite omaglicu, nemojte voziti niti upravljati strojevima.
English: Late OHSS occurs more than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy.
Croatian: Kasni OHSS javlja se više od 10 dana nakon primjene hCG-a, kao posljedica hormonskih promjena tijekom trudnoće.
English: Results of a small uncontrolled study suggest a higher ovarian response than in combination with a GnRH antagonist.
Croatian: Rezultati malog nekontroliranog ispitivanja ukazuju na jači odgovor jajnika nego u kombinaciji s antagonistom GnRH.