FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu-Te exceed the risks for the approved indication and recommended that ProteqFlu-Te be given a marketing authorisation.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi ProteqFlu-Te premašuju rizike za odobrene indikacije i preporučio je izdavanje odobrenja za stavljanje ProteqFlu-Te u promet.
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 infekcije ili nedostatnog uzimanja kolostruma, može se dati dodatna inicijalna injekcija ProteqFlu-Te u dobi od 4 mjeseca nakon čega slijedi program potpunog cijepljenja (prvo cijepljenje i ponovna cijepljenja).
English: The withdrawal period for ProtequFlu-Te for meat and milk is zero days.
Croatian: Karencija za ProteqFlu-Te za meso i mlijeko iznosi nula dana.
English: The vaccine also contains a tetanus toxoid which is a tetanus toxin processed in order to decrease its toxic effect, but retain its antigenic power.
Croatian: Cjepivo također sadrži toksoid tetanusa koji je prerađeni toksin tetanusa kako bi se smanjio njegov toksični učinak, ali zadržala antigenska moć.
English: ProteqFlu-Te is a vaccine which was produced with the use of recombinant DNA technology.
Croatian: ProteqFlu-Te je cjepivo proizvedeno uporabom tehnologije rekombinantne DNK.
English: ProteqFlu-Te contains an adjuvant (carbomer) to enhance the immune response.
Croatian: ProteqFlu-Te sadrži adjuvans (karbomer) za pojačavanje imunološkog odgovora.
English: This means that a gene from two different equine influenza strains (A/eq/Ohio/03 and A/eq/Richmond/1/07) was inserted in to 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 od dva različita soja 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 proteina sojeva influence.
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 (najvećeg promjera 5 cm) koje se obično tijekom 4 dana smanjuje.
English: The vaccine is given as an intramuscular injection (injection into a muscle).
Croatian: Cjepivo se daje u obliku intramuskularne injekcije (injekcije u mišić).
English: The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles.
Croatian: Za bolest koja obično nastaje u kontaminiranim ranama, karakteristična je opća rigidnost (ukočenost) i konvulzivni grčevimišića.
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 and the tetanus bacterium.
Croatian: Imunološki sustav potom će moći brže proizvesti ta zaštitna protutijela kad životinja bude prirodno izložena virusima konjske gripe i bakteriji tetanusa.
English: This should be followed by revaccination 5 months later, and afterwards by booster vaccinations every two years for protection against tetanus or for protection against influenza vaccination every year alternating with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum two years for tetanus.
Croatian: Nakon toga treba uslijediti ponovno cijepljenje 5 mjeseci kasnije i nakon toga docjepljivanje svake dvije godine za zaštitu od tetanusa ili svake godine za zaštitu od influence izmjenično cjepivom ProteqFlu ili ProteqFlu-Te, poštujući interval od najviše dvije godine za tetanus.
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, treba odmah potražiti pomoć liječnika i pokazati mu uputu o proizvodu ili etiketu.
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 competitive 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: ProteqFlu-Te is a vaccine for use in horses.
Croatian: ProteqFlu-Te je cjepivo za konje.
English: Why has ProteqFlu-Te been approved?
Croatian: Zašto je ProteqFlu-Te odobren?
English: The duration of protection was 5 months after primary vaccination and one year for the equine influenza and two years for the tetanus after the third vaccination.
Croatian: Trajanje zaštite iznosilo je 5 mjeseci nakon prvog cijepljenja i godinu dana za influencu konja i dvije godine za tetanus nakon trećeg cijepljenja.
English: The vaccine reduces the clinical signs of equine influenza and the excretion (shedding) of the virus after infection.
Croatian: Cjepivo reducira kliničke znakove konjske influence i ekskreciju (izlučivanje) virusa nakon infekcije.
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 consumption or milk used for consumption.
Croatian: Karencija je razdoblje koje treba proćinakon primjene lijeka, a prije nego što se životinja smije zaklati, a njezino meso ili mlijeko koristiti za ljudsku prehranu.
English: The measure of effectiveness in all studies was antibody levels of against the two influenza vaccine strains and against tetanus toxoid.
Croatian: Mjera djelotvornosti u svim ispitivanjima bila je razina protutijela protiv dva soja virusa influence i protiv toksoida tetanusa.
English: When ProteqFlu-Te is given to horses, the animals' immune system recognises the specific proteins from the equine influenza strains and the tetanus toxoid as ‘foreign' and makes antibodies against them.
Croatian: Nakon što se ProteqFlu-Te da konjima, imunološki sustav životinja prepoznaje specifične proteine sojeva influence konja i toksoid tetanusa kao „strana tijela” i proizvodi protutijela.
English: The studies showed that ProteqFlu-Te was effective in reducing clinical signs and virus excretion after infection with equine influenza, and against tetanus to prevent mortality from 14 days after primary vaccination.
Croatian: Ispitivanja su pokazala da je ProteqFlu-Te djelotvoran u redukciji kliničkih znakova i ekskreciji virusa nakon infekcije influencom konja te protiv tetanusa u svrhu sprječavanja smrtnosti 14 dana nakon prvog cijepljenja.
English: The current formulation of ProteqFlu-Te produced similar antibody responses against the two flu strains and tetanus toxoid included in the vaccine to those seen in the main studies.
Croatian: Trenutna formulacija cjepiva ProteqFlu-Te proizvela je odgovore protutijela protiv dva soja virusa gripe i toksoida tetanusa uključenih u cjepivo slične onima uočenim u glavnom ispitivanju.
English: It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively, and a tetanus toxoid (chemically weakened toxins from the tetanus bacterium).
Croatian: Sadrži dijelove dva soja konjskog virusa influence koji su umetnuti u vektor (nositelj) virusa boginja kanarinca te toksoid tetanusa (kemijski oslabljeni toksini iz bakterija tetanusa).
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika opisan je u modulu sa znanstvenim raspravama ovog EPAR-a.
English: What is ProteqFlu-Te used for?
Croatian: Za što se ProteqFlu-Te koristi?
English: What is the risk associated with ProteqFlu-Te?
Croatian: Koji su rizici povezani s VMP-om ProteqFlu-Te?
English: ProteqFlu-Te is used to vaccinate horses from 4 months of age against equine influenza and tetanus.
Croatian: ProteqFlu-Te koristi se za cijepljenje konja starosti od 4 mjeseca, a protiv konjske influence i tetanusa.
English: This will help to protect against equine influenza and tetanus.
Croatian: To će pomoći u zaštiti od konjske influence i tetanusa.
English: Equine influenza and tetanus vaccine
Croatian: Cjepivo protiv influence konja i tetanusa
English: What benefit has ProteqFlu-Te shown during the studies?
Croatian: Koje su koristi VMP-a ProteqFlu-Te utvrđene u ispitivanjima?
English: How has ProteqFlu-Te been studied?
Croatian: Kako je ProteqFlu-Te ispitivan?
English: How does ProteqFlu-Te work?
Croatian: Kako djeluje ProteqFlu-Te?
English: What is ProteqFlu-Te?
Croatian: Što je ProteqFlu-Te?
English: It may request a reexamination of the opinion within 15 days of receipt of notification of this negative opinion.
Croatian: Tvrtka može zatražiti ponovno ispitivanje mišljenja u roku od 15 dana od primitka obavijesti o ovom negativnom mišljenju.
English: The company presented the results of 4 main studies involving a total of 588 patients.
Croatian: Tvrtka je dostavila rezultate iz četiriju glavnih ispitivanja koja su obuhvatila ukupno 588 bolesnika.
English: It was to be available as capsules to be taken by mouth.
Croatian: Trebao je biti dostupan u obliku kapsula koje se uzimaju kroz usta.
English: The main measures of effectiveness were the amount of sperm produced and testosterone levels.
Croatian: Glavna mjerila djelotvornosti bile su količina proizvedene sperme i razine testosterona.
English: EnCyzix was to be used in overweight men with a body mass index (BMI) of at least 25 kg/m2.
Croatian: Lijek EnCyzix trebao se primjenjivati u muškaraca s prekomjernom tjelesnom težinom u kojih je indeks tjelesne mase (BMI) najmanje 25 kg/m2.
English: This stops the release of other hormones called gonadotrophins, which are needed for the testes to produce testosterone and to work normally.
Croatian: To zaustavlja otpuštanje drugih hormona koji se nazivaju gonadotropinima, koji su potrebni kako bi testisi proizvodili testosteron i normalno funkcionirali.
English: What is EnCyzix?
Croatian: Što je EnCyzix?
English: In addition, there is a risk of venous thromboembolism (problems due to the formation of blood clots in the veins) with the medicine.
Croatian: Nadalje, postoji rizik od venskog tromboembolizma (problema uslijed stvaranja krvnih ugrušaka u venama) zbog primjene lijeka.
English: In this condition, the sex organs (the testes in men) do not work properly resulting in symptoms such as infertility, low libido, impotence, weakened bones and weight gain.
Croatian: Kod ovog stanja spolni organi (testisi u muškaraca) ne funkcioniraju ispravno, što uzrokuje simptome kao što su neplodnost, niski libido, impotencija, oslabljene kosti i povećanje tjelesne mase.
English: Refusal of the marketing authorisation for EnCyzix (enclomifene) EMA/CHMP/54473/2018
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka EnCyzix (enklomifen) EMA/CHMP/54473/2018
English: Overweight men with hypogonadotropic hypogonadism produce too much of the hormone oestrogen.
Croatian: Muškarci s prekomjernom tjelesnom težinom koji boluju od hipogonadotropnog hipogonadizma proizvode previše hormona estrogena.
English: The company that applied for authorisation is Renable Pharma Limited.
Croatian: Zahtjev za izdavanje odobrenja podnijela je tvrtka Renable Pharma Limited.
English: Refusal of the marketing authorisation for EnCyzix (enclomifene)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka EnCyzix (enklomifen)
English: EnCyzix was expected to be used to treat hypogonadotropic hypogonadism in men.
Croatian: EnCyzix se trebao koristiti za liječenje hipogonadotropnog hipogonadizma u muškaraca.
English: The CHMP noted that although the studies showed an increase in testosterone levels with EnCyzix, they did not look at whether EnCyzix would improve symptoms such as bone strength, weight gain, impotence and libido.
Croatian: CHMP je primijetio da, iako su ispitivanja pokazala povećanje razine testosterona s lijekom EnCyzix, njima nije ispitivano može li EnCyzix povoljno djelovati na simptome kao što su čvrstoća kostiju, dobivanje na težini, impotencija i libido.
English: EnCyzix blocks the excess oestrogen enabling release of gonadotrophins and normal testicular function.
Croatian: Lijek EnCyzix blokira višak estrogena, čime omogućuje oslobađanje gonadotropina i normalnu funkciju testisa.
English: What was EnCyzix expected to be used for?
Croatian: Za što se EnCyzix trebao koristiti?
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with EnCyzix.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja ili programa milosrdnog davanja lijeka EnCyzix koji su u tijeku.
English: Therefore, the CHMP was of the opinion that the benefits of EnCyzix did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je CHMP smatrao da koristi lijeka EnCyzix ne nadmašuju s njim povezane rizike te je preporučio odbijanje izdavanja odobrenja za stavljanje lijeka u promet.
English: EnCyzix is a medicine that contains the active substance enclomifene.
Croatian: EnCyzix je lijek koji sadrži djelatnu tvar enklomifen.
English: How does EnCyzix work?
Croatian: Kako djeluje EnCyzix?
English: On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product EnCyzix, intended for the treatment of hypogonadotropic hypogonadism in men.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje davanja odobrenja za stavljanje u promet lijeka EnCyzix, koji je namijenjen liječenju hipogonadotropnog hipogonadizma u muškaraca.
English: Patients were given either EnCyzix, or placebo (a dummy treatment) with and without application of a testosterone gel.
Croatian: Oni su primali EnCyzix ili placebo (prividno liječenje) uz primjenu testosteronskog gela i bez njegove primjene.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 May 2015 EMA/325007/2015
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22. svibnja 2015. EMA/325007/2015
English: by washing your hands.
Croatian: tako da operete ruke.
English: Read both sides for full instructions
Croatian: Pročitati obje strane za cjelovite upute.
English: WHERE TO LEARN MORE
Croatian: GDJE DOZNATI VIŠE
English: I'm not sure my pen worked correctly.
Croatian: Nisam siguran je li brizgalica radila ispravno.
English: Please keep this in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines).
Croatian: Imajte to na umu u svim situacijama u kojima sebe i druge možete izložiti riziku (npr. pri upravljanju vozilom ili radu sa strojevima).
English: • Trulicity is administered once a week.
Croatian: • Trulicity se primjenjuje jedanput na tjedan.
English: Change (rotate) your injection site each week.
Croatian: • Mijenjajte (rotirajte) mjesto injiciranja svaki tjedan.
English: Check to see if you have received your dose.
Croatian: Provjerite jeste li primili dozu.
English: Some patients may hear a soft click right before the second loud click.
Croatian: Neki bolesnici mogu čuti tiši klik neposredno prije drugoga glasnog klika.
English: The clinical relevance of these findings is currently unknown.
Croatian: Klinički značaj tih nalaza trenutno je nepoznat.
English: Your doctor may need to change your dose of these other medicines to reduce this risk.
Croatian: Liječnik će Vam možda morati promijeniti dozu tih drugih lijekova kako bi smanjio taj rizik.
English: pharmacist or nurse.
Croatian: ljekarnik ili medicinska sestra.
English: I heard more than two clicks during my injection - two louder clicks and a soft one.
Croatian: Čuo sam više od dva klika tijekom injekcije - dva glasnija i jedan tiši.
English: How can I tell if I have completed my injection?
Croatian: Kako ću znati jesam li završio injekciju?
English: The safety and efficacy of dulaglutide in children aged less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost dulaglutida u djece mlađe od 18 godina nisu još ustanovljene.
English: These side effects are usually not severe.
Croatian: Ove nuspojave obično nisu teške.
English: These effects were sustained to the end of the study (104 weeks).
Croatian: Navedeni su se učinci održali do kraja ispitivanja (104 tjedna).
English: This is not necessary, but it may help you keep the pen steady and firm against your skin.
Croatian: Nije potrebno, ali možda ćete tako lakše držati brizgalicu nepomičnom i čvrsto pritisnutom uz kožu.
English: With your other hand, hold the syringe like a pencil.
Croatian: Drugom rukom držite štrcaljku poput olovke.
English: The median study follow-up time was 5.4 years.
Croatian: Medijan praćenja u sklopu ispitivanja iznosio je 5,4 godine.
English: If you drop it on a hard surface, do not use it.
Croatian: Ako Vam padne na tvrdu površinu, nemojte je upotrijebiti.
English: BEFORE YOU GET STARTED Remove
Croatian: PRIJE NEGO ŠTO POČNETE
English: In the absence of compatibility studies this 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: These other medicines may be medicines taken by mouth and/or insulin given by injection.
Croatian: Ti drugi lijekovi mogu biti lijekovi koji se uzimaju kroz usta i/ili inzulin koji se primjenjuje injekcijom.
English: Body weight or body mass index
Croatian: Tjelesna težina ili indeks tjelesne mase
English: • Do not share your syringe with anyone else.
Croatian: • Nemojte dijeliti svoju štrcaljku s drugima.
English: - you have severe problems with food digestion or food remaining in your stomach for longer than normal (including gastroparesis).
Croatian: - ako imate teških tegoba s probavljanjem hrane ili ako Vam se hrana zadržava u želucu dulje nego što je to normalno (uključujući gastroparezu).
English: • in addition to other medicinal products for the treatment of diabetes.
Croatian: • kao dodatak drugim lijekovima za liječenje šećerne bolesti.
English: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000 and not known: cannot be estimated from available data).
Croatian: ≥ 1/1000 i < 1/100; rijetko: ≥ 1/10 000 i < 1/1000, vrlo rijetko: < 1/10 000; nepoznato: ne može se procijeniti na temelju dostupnih podataka).
English: In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Croatian: U slučaju predoziranja, potrebno je uvesti odgovarajuće potporno liječenje u skladu s bolesnikovim kliničkim znakovima i simptomima.
English: Trulicity is not recommended for children and adolescents under 18 years of age because it has not been studied in these patients.
Croatian: Primjena lijeka Trulicity ne preporučuje se u djece i adolescenata mlađih od 18 godina jer u tih bolesnika lijek nije ispitivan.
English: You may give them an infection or get an infection from them.
Croatian: Možete im prenijeti infekciju ili oni Vama mogu prenijeti infekciju.
English: Do not remove the pen from your skin until you hear the second louder click.
Croatian: Nemojte odvajati brizgalicu od kože prije nego što čujete drugi glasniji klik.
English: While metoprolol tmax was delayed by 1 hour, this change was not statistically significant.
Croatian: Iako je nastup tmax metoprolola bio odgođen za 1 sat, ta promjena nije bila statistički značajna.
English: Dulaglutide is not a substitute for insulin.
Croatian: Dulaglutid nije zamjena za inzulin.
English: You may want to mark your calendar to remind you when to inject your next dose.
Croatian: Možda ćete htjeti označiti datum na kalendaru kako biste se podsjetili kada injicirati sljedeću dozu.
English: Week 1 Week 2 Week 3 Week 4
Croatian: 1. tjedan 2. tjedan 3. tjedan 4. tjedan
English: Meta-analysis of phase II and III studies
Croatian: Metaanaliza ispitivanja faze II i faze III
English: • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
Croatian: • kao monoterapija kada se primjena metformina ne smatra prikladnom zbog nepodnošljivosti ili kontraindikacija
English: 104 weeks
Croatian: 104 tjedna
English: (below 30°C) for up to a total of 14 days.
Croatian: 30ºC) tijekom najviše 14 dana.
English: IMPORTANT INFORMATION
Croatian: VAŽNE INFORMACIJE
English: Patients should be informed of the characteristic symptoms of acute pancreatitis.
Croatian: Bolesnike se mora upozoriti na karakteristične simptome akutnog pankreatitisa.
English: Sitagliptin can produce up to 80 % inhibition of DPP-4 over a 24-hour period.
Croatian: Sitagliptinom se može postići do 80% inhibicije DPP-4 tijekom 24-satnog razdoblja.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeat-dose toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksičnosti ponovljenih doza.
English: Leave the Base Cap on until you are ready to inject.
Croatian: Nemojte skidati zatvarač baze dok ne budete spremni za injiciranje.
English: This occurs when the needle starts retracting in about 5-10 seconds.
Croatian: Čut ćete ga kada se igla počne izvlačiti iz kože nakon približno 5-10 sekundi.
English: Press and hold the green injection button; you will hear a loud click.
Croatian: 3 PRITISNITE I DRŽITE • Pritisnite zeleni gumb za injiciranje i držite ga pritisnutim; čut ćete glasan klik.
English: What Trulicity is and what it is used for
Croatian: Što je Trulicity i za što se koristi
English: Glass syringe (type I).
Croatian: Staklena štrcaljka (staklo tipa I).
English: It should not be administered intravenously or intramuscularly.
Croatian: Ne smije se primjenjivati intravenski niti intramuskularno.
English: Pull off and discard the grey base cap.
Croatian: • Skinite i bacite sivi zatvarač baze.
English: This change is not expected to have clinical consequences.
Croatian: Ne očekuje se da će ta promjena imati kliničkih posljedica.
English: COMMONLY ASKED QUESTIONS
Croatian: Česta pitanja
English: Because Trulicity can slow stomach emptying which could affect other medicines, tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicine.
Croatian: Budući da Trulicity može usporiti pražnjenje želuca i tako utjecati na druge lijekove, obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: Trulicity has no or negligible influence on the ability to drive or use machines.
Croatian: Trulicity ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Change in body weight
Croatian: Promjena tjelesne težine
English: OTHER INFORMATION
Croatian: DRUGE INFORMACIJE
English: Do not remove the base cap and do not use the pen.
Croatian: Nemojte skinuti zatvarač baze i nemojte upotrijebiti brizgalicu.
English: Insert the needle into your skin at about a 45-degree angle.
Croatian: Ubodite iglu u kožu pod kutom od približno 45 stupnjeva.
English: What you need to know before you use Trulicity
Croatian: Što morate znati prije nego počnete primjenjivati Trulicity
English: You may use the same area of your body, but be sure to choose a different injection site in that area.
Croatian: Lijek možete primijeniti na istome dijelu tijela, ali obavezno odaberite drugo mjesto za injiciranje unutar tog područja.
English: It is important to avoid dehydration by drinking plenty of fluids.
Croatian: Važno je izbjeći dehidraciju unosom dovoljne količine tekućina.