FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Invega, paliperidone, is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Croatian: Djelatna tvar lijeka Invega, paliperidon, poznat je pod nazivom „atipičan” antipsihotik jer se razlikuje od starijih antipsihotika koji su dostupni od 1950-tih godina.
English: In an additional longer-term study involving 207 adults with schizophrenia who had initially been treated over 14 weeks, Invega was more effective than placebo in preventing new symptoms for up to 35 weeks.
Croatian: U dodatnom dugoročnom ispitivanju koje je obuhvatilo 207 odraslih osoba sa shizofrenijom prvotno liječenih tijekom 14 tjedana, lijek Invega bio je djelotvorniji od placeba u sprječavanju pojave novih simptoma do 35 tjedana.
English: Three short-term studies innvolving 1,692 adults showed that Invega is more effective than placebo (a dummy treatment) and as effective as another antipsychotic medicine olanzapine at reducing symptoms of schizophrenia (as measured by a standard rating scale).
Croatian: U trima kratkoročnim ispitivanjima koja su obuhvatila 1692 odrasle osobe dokazano je da je lijek Invega djelotvorniji od placeba (prividno liječenje) te da je jednako djelotvoran u smanjenju simptoma shizofrenije (prema standardnoj ljestvici ocjenjivanja) kao drugi antipsihotik, olanzapin.
English: How does Invega work?
Croatian: Kako djeluje Invega?
English: What benefits of Invega have been shown in studies?
Croatian: Koje su koristi lijeka Invega dokazane u ispitivanjima?
English: Invega must not be taken by people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.
Croatian: Lijek Invega ne smiju uzimati osobe koje su preosjetljive (alergične) na paliperidon ili bilo koji drugi sastojak, ili na risperidon.
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another atypical antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Croatian: Paliperidon je aktivan proizvod razgradnje (metabolit) risperidona, drugog atipičnog antipsihotika koji se primjenjuje u liječenju shizofrenije od 1990-tih godina.
English: For practical information about using Invega, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Invega bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Symptom scores fell by 19.9 points in those taking olanzapine.
Croatian: Rezultati simptoma u osoba koje su primile olanzapin pali su za 19,9 bodova.
English: For more information about treatment with Invega, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Invega pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svojem liječniku ili ljekarniku.
English: In another study, the fall in symptom score for mania after 6 weeks was 20.0 in the Invega group and 10.8 in the placebo group.
Croatian: U drugom ispitivanju pad u rezultatu simptoma manije nakon šest tjedana liječenja iznosio je 20,0 u skupini koja je primila lijek Invega i 10,8 u skupini koja je primila placebo.
English: Invega contains the active substance paliperidone.
Croatian: Lijek Invega sadržava djelatnu tvar paliperidon.
English: In one of these studies, average symptom scores fell by between 17.9 and 23.3 points after 6 weeks in those taking Invega compared with a fall of 4.1 points with placebo.
Croatian: Prosječni rezultati simptoma u jednom od tih ispitivanja pali su između 17,9 i 23,3 boda nakon šest tjedana u osoba koje su primile lijek Invega, u usporedbi sa smanjenjem od 4,1 boda u osoba koje su primile placebo.
English: In one study, patients who were given Invega had a fall in their symptom score for mania of between 27.4 and 30.6 after 6 weeks compared with 21.7 in patients who were given placebo.
Croatian: U jednom ispitivanju bolesnici koji su primili lijek Invega imali su pad u rezultatu simptoma manije između 27,4 i 30,6 nakon šest tjedana liječenja u usporedbi s 21,7 u bolesnika koji su primili placebo.
English: Invega is also used to treat adults with schizoaffective disorder.
Croatian: Lijek Invega također se primjenjuje u liječenju shizoafektivnih poremećaja u odraslih osoba.
English: How is Invega used?
Croatian: Kako se Invega koristi?
English: Invega can only be obtained with a prescription.
Croatian: Lijek Invega izdaje se samo na liječnički recept.
English: Other information about Invega
Croatian: Ostale informacije o lijeku Invega
English: For the full list of all side effects reported with Invega, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Invega potražite u uputi o lijeku.
English: In adolescents with schizophrenia the maximum daily dose depends on the patient's body weight and should not be more than 6 mg in those who weigh less than 51 kg. For more information on the use of Invega, including the adjustment of doses in those with kidney disease and the elderly, see the summary of product characteristics (also part of the EPAR).
Croatian: U adolescenata sa shizofrenijom maksimalna dnevna doza ovisi o tjelesnoj težini bolesnika i ne smije iznositi više od 6 mg u osoba koje imaju manje od 51 kg.
English: It is given once daily for up to two weeks.
Croatian: Primjenjuje se jednom dnevno tijekom najviše dva tjedna.
English: Meloxicam
Croatian: Meloksikam
English: It is either given with food or directly into the mouth at a dosage of 0.6 mg/kg bodyweight.
Croatian: Primjenjuje se pomiješano s hranom ili izravno u usta u dozi od 0,6 mg/kg tjelesne težine.
English: Novaquin is a ‘generic medicine'.
Croatian: Novaquin je „generički lijek”.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila ovaj veterinarsko-medicinski proizvod (VMP) kako bi preporučila njegovo odobrenje u Europskoj uniji (EU) i uvjete za njegovu primjenu.
English: This summary was last updated in July 2015.
Croatian: Sažetak je posljednji put ažuriran u 07-2015.
English: The full EPAR for Novaquin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Novaquin nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva su VMP-a bioekvivalentna kada u tijelu proizvode iste razine djelatne tvari.
English: The withdrawal period for meat from horses treated with Novaquin is three days.
Croatian: Razdoblje karencije za meso konja liječenih VMP-om Novaquin iznosi tri dana.
English: Novaquin is available as a 15 mg/ml oral suspension and can only be obtained with a prescription.
Croatian: Novaquin je dostupan kao peroralna suspenzija od 15 mg/ml i izdaje se samo na recept.
English: Other information about Novaquin
Croatian: Ostale informacije o VMP-u Novaquin
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Cjeloviti EPAR za referentni VMP nalazi se i na internetskim stranicama Agencije.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during inflammation) and fever, meloxicam reduces these signs of disease.
Croatian: S obzirom na to da su prostaglandini tvari koje potiču upalu, bol, eksudaciju (tekućina koja curi iz krvnih žila tijekom upale) i vrućicu, meloksikam smanjuje ove znakove bolesti.
English: Novaquin is a veterinary medicine used for the alleviation of inflammation and relief of pain and chronic musculoskeletal disorders (disorders affecting the muscle and bones) in horses.
Croatian: Novaquin je veterinarsko-medicinski proizvod (VMP) koji se koristi za smanjivanje upale i ublažavanje boli kod kroničnih mišićnokoštanih poremećaja (poremećaji koji utječu na mišiće i kosti) u konja.
English: What is Novaquin and what is it used for?
Croatian: Što je Novaquin i za što se koristi?
English: Therefore, the CVMP's view was that, as for Metacam, the benefits outweigh the identified risks.
Croatian: Stoga je stav CVMP-a da u slučaju VMP-a Metacam koristi nadmašuju utvrđene rizike.
English: What are the benefits and risks of Novaquin?
Croatian: Koje su koristi i rizici VMP-a Novaquin?
English: Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Croatian: Meloksikam djeluje tako da blokira ciklooksigenazu, enzim koji je uključen u proizvodnju prostaglandina.
English: It is not intended to provide practical advice on how to use Novaquin.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Novaquin.
English: Novaquin contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Croatian: Novaquin sadrži meloksikam, koji pripada skupini lijekova koji se zovu nesteroidni protuupalni lijekovi (NSAID).
English: The European Commission granted a marketing authorisation valid throughout the EU for Novaquin on 8 September 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Novaquin na snazi u Europskoj uniji od 8. rujna 2015.
English: Why is Novaquin approved?
Croatian: Zašto je Novaquin odobren?
English: The medicine is not authorised for use in horses producing milk for human consumption.
Croatian: VMP nije odobren za primjenu na konje od kojih se dobiva mlijeko za ljudsku potrošnju.
English: This means that Novaquin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
Croatian: To znači da je Novaquin sličan „referentnom VMP-u” koji je već odobren u Europskoj uniji pod nazivom Metacam.
English: It contains the active substance meloxicam.
Croatian: Sadrži djelatnu tvar meloksikam.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Novaquin has been shown to have comparable quality and to be bioequivalent to Metacam.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je kako je, u skladu s preduvjetima EU-a, potvrđeno da Novaquin posjeduje usporedivu kvalitetu te je bioekvivalentan/usporediv s VMP-om Metacam.
English: This is a summary of the European public assessment report (EPAR) for Novaquin.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o veterinarsko-medicinskom proizvodu Novaquin.
English: For more information about treatment with Novaquin, read the package leaflet (also part of the EPAR) or contact your veterinarian or pharmacist.
Croatian: Više informacija o terapiji VMPom Novaquin pročitajte u uputi o VMP-u (također dio EPAR-a), ili se obratite svom veterinaru ili ljekarniku.
English: It is also the time required after administration of a medicine before milk or 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: The Committee recommended that Novaquin be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet VMP-a Novaquin u EU-u.
English: Because Novaquin is a generic medicine, studies in animals have been limited to tests to determine that it is bioequivalent to the reference medicine, Metacam.
Croatian: Budući da je Novaquin generički VMP, ispitivanja na životinjama bila su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom VMP-u Metacamu.
English: Because Novaquin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Novaquin generički VMP te je bioekvivalent referentnom VMP-u, smatra se da su njegove koristi i rizici isti kao i oni referentnog VMP-a.
English: For practical information about using Novaquin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Novaquin vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći nakon primjene VMP-a i prije klanja životinje i korištenja mesa za prehranu ljudi.
English: How is Novaquin used?
Croatian: Kako se Novaquin koristi?
English: How does Novaquin work?
Croatian: Kako djeluje Novaquin?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Novaquin, including the precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u Novaquin nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: How has Novaquin been studied?
Croatian: Kako je Novaquin ispitivan?
English: Drink plenty of fluids.
Croatian: Pijte mnogo tekućine.
English: Date of first authorisation: 27 September 2018
Croatian: Datum prvog odobrenja: 27. rujan 2018.
English: Swallow the tablet whole with a glass of water.
Croatian: Tabletu progutajte cijelu, s čašom vode.
English: Visceral crisis
Croatian: Visceralna kriza
English: A risk to newborns/infants cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenčad/dojenčad.
English: Like all medicines, this medicine can cause side-effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Patients should take the doses at approximately the same times every day.
Croatian: Bolesnice trebaju uzimati dozu svaki dan u približno isto vrijeme.
English: - The other ingredients in this medicine are:
Croatian: Drugi sastojci ovog lijeka su:
English: de la Industria, 30 28108 Alcobendas, Madrid Spain
Croatian: Avda. de la Industria, 30 28108 Alcobendas, Madrid Španjolska
English: Fatal events occurred in <1% of patients.
Croatian: Smrtni slučajevi zabilježeni su u < 1% bolesnica.
English: Toxicitya, b
Croatian: Toksičnosta, b
English: Verzenios is not to be used in children and adolescents under 18 years of age.
Croatian: Verzenios se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: Febrile neutropenia was reported in 0.9% patients.
Croatian: Febrilna neutropenija prijavljena je u 0,9% bolesnica.
English: These changes were not considered to be clinically relevant.
Croatian: Te se promjene nisu smatrale klinički značajnima.
English: The safety and efficacy of abemaciclib in children and adolescents aged less than 18 years has not been established.
Croatian: Sigurnost i djelotvornost abemacikliba u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: It is currently unknown whether abemaciclib may reduce the effectiveness of systemically acting hormonal contraceptives.
Croatian: Trenutno nije poznato može li abemaciklib smanjiti učinkovitost sistemskih hormonskih kontraceptiva.
English: In animal studies, no effects on female reproductive organs were observed.
Croatian: U ispitivanjima na životinjama nisu opaženi učinci na reproduktivne organe ženki.
English: Medical treatment may be necessary.
Croatian: Možda će Vam biti potrebno liječenje.
English: Morning Evening
Croatian: Ujutro
English: Avoid grapefruit or grapefruit juice while you are taking the medicine as they may increase the concentration of Verzenios in the blood.
Croatian: Izbjegavajte grejp i sok od grejpa dok uzimate ovaj lijek jer oni mogu povećati koncentraciju lijeka Verzenios u krvi.
English: Discuss contraception with your doctor if there is any possibility that you may become pregnant.
Croatian: Razgovarajte s liječnikom o kontracepciji ako postoji ikakva mogućnost da zatrudnite.
English: What Verzenios is and what it is used for
Croatian: Što je Verzenios i za što se koristi
English: The dose can be taken with or without food.
Croatian: Doza se može uzimati s hranom ili bez nje.
English: • Reduction in white blood cells, red blood cells, and blood platelets
Croatian: • smanjen broj bijelih krvnih stanica, crvenih krvnih stanica i krvnih pločica
English: a NCI CTCAE ULN = upper limit of normal
Croatian: a NCI CTCAE GGN = gornja granica normale
English: See section 4 “Possible side effects”, and talk to your doctor if you have any symptoms.
Croatian: Pogledajte dio 4 „Moguće nuspojave“ i obratite se liječniku u slučaju pojave bilo kakvih simptoma.
English: Other medicines and Verzenios
Croatian: Drugi lijekovi i Verzenios
English: The effect of abemaciclib on the QTcF interval was evaluated in 144 patients with advanced cancer.
Croatian: Učinak abemacikliba na QTcF interval ocjenjivao se u 144 bolesnice s uznapredovalim rakom.
English: Therefore, abemaciclib can be taken with or without food.
Croatian: Stoga se abemaciklib može uzimati s hranom ili bez nje.
English: Blocking the action of these proteins can slow down growth of cancer cells, shrink the tumour and delay progression of the cancer.
Croatian: Blokiranjem djelovanja tih proteina može se usporiti rast stanica raka, smanjiti tumor i odgoditi napredovanje raka.
English: Do not stop taking Verzenios unless your doctor tells you to.
Croatian: Nemojte prestati uzimati lijek Verzenios, osim ako Vam to ne kaže liječnik.
English: Verzenios with food and drink
Croatian: Verzenios s hranom i pićem
English: These could be a sign of low white blood cell counts (which may affect more than 1 in 10 people) and should be treated immediately.
Croatian: To mogu biti znakovi niske razine bijelih krvnih stanica (mogu se javiti u više od 1 na 10 osoba) i potrebno ih je odmah liječiti.
English: Take Verzenios twice daily, at about the same time every day, preferably in the morning and evening, so there is enough medicine in your body all the time.
Croatian: Verzenios uzimajte dvaput na dan, svaki dan u približno isto vrijeme, po mogućnosti ujutro i navečer, kako bi u Vašem tijelu stalno bila prisutna dovoljna količina lijeka.
English: • medicines that may increase the concentration of Verzenios in the blood:
Croatian: • lijekove koji mogu povećati koncentraciju lijeka Verzenios u krvi:
English: o Clarithromycin (antibiotic used to treat bacterial infections)
Croatian: o klaritromicin (antibiotik koji se koristi za liječenje bakterijskih infekcija)
English: The half-life of abemaciclib increased from 24 to 55 hours (see section 4.2).
Croatian: Poluvijek abemacikliba produljio se s 24 na 55 sati (vidjeti dio 4.2).
English: Verzenios has minor influence on the ability to drive and use machines.
Croatian: Verzenios ima mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Incidence was greatest during the first month of abemaciclib treatment and was lower subsequently.
Croatian: Njegova je incidencija bila najveća tijekom prvog mjeseca liječenja abemaciklibom, da bi se nakon toga smanjila.
English: Avoid grapefruit or grapefruit juice.
Croatian: Treba izbjegavati grejp i sok od grejpa.
English: It should not be taken with grapefruit or grapefruit juice (see section 4.5).
Croatian: Ne smije se uzimati s grejpom ili sokom od grejpa (vidjeti dio 4.5).
English: The tablet should be swallowed whole (patients should not chew, crush, or split tablets before swallowing).
Croatian: Tabletu treba progutati cijelu (bolesnice ne smiju žvakati, drobiti ni lomiti tablete prije gutanja).
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ukazala su na reproduktivnu toksičnost (vidjeti dio 5.3).
English: Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Tables 1-5.
Croatian: Liječenje nekih nuspojava može zahtijevati privremen prekid primjene i/ili smanjenje doze na način prikazan u Tablicama 1 - 5.
English: There are no data on the efficacy and safety of abemaciclib in patients with visceral crisis.
Croatian: Nema podataka o djelotvornosti i sigurnosti abemacikliba u bolesnica s visceralnom krizom.
English: Do not chew, crush or split the tablets before swallowing.
Croatian: Nemojte žvakati, drobiti ni lomiti tablete prije gutanja.
English: What Verzenios looks like and contents of the pack
Croatian: Kako Verzenios izgleda i sadržaj pakiranja
English: Age, gender, and body weight
Croatian: Posebne populacije Dob, spol i tjelesna težina
English: Complete or partial recovery was observed for all target organs at the end of the 28-day recovery period.
Croatian: Na kraju 28-dnevnog razdoblja oporavka opažen je potpun ili djelomičan oporavak svih ciljnih organa.
English: • Alteration in sense of taste
Croatian: • promjena osjeta okusa
English: • Hair loss
Croatian: • opadanje kose
English: Objective response for patients with measurable diseasea
Croatian: Objektivan odgovor u bolesnica s mjerljivom bolešćua
English: Discontinue abemaciclib.
Croatian: Prekinuti primjenu abemacikliba.
English: Diarrhoea can be associated with dehydration.
Croatian: Proljev može biti praćen dehidracijom.
English: Verzenios should be taken continuously as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
Croatian: Verzenios treba uzimati neprekidno sve dok bolesnica ostvaruje kliničku korist od terapije ili do pojave neprihvatljive toksičnosti.
English: General supportive care should be provided.
Croatian: Bolesnicama treba pružiti opću potpornu skrb.
English: Grade 3 or 4 a NCI CTCAE
Croatian: 3. ili 4. stupanj a NCI CTCAE
English: Patients should be instructed to report any episode of fever to their healthcare provider.
Croatian: Bolesnice treba uputiti da svaku epizodu vrućice prijave svom liječniku.
English: Do not take a double dose to make up for the forgotten or vomited dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu ili dozu koju ste povratili.
English: When and how to take Verzenios
Croatian: Kada i kako uzimati Verzenios
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Preporučena doza Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
English: If you stop taking Verzenios
Croatian: Ako prestanete uzimati Verzenios
English: Resume at next lower dose.
Croatian: Nastaviti liječenje sljedećom manjom dozom.
English: The geometric mean systemic volume of distribution is approximately 750 L (69% CV), indicating distribution of abemaciclib into tissues.
Croatian: Geometrijska srednja vrijednost sistemskog volumena distribucije iznosi približno 750 l (69% CV), što ukazuje na distribuciju abemacikliba u tkiva.
English: Infections/infestations
Croatian: Infekcije/infestacije
English: Grade 2 that persists or recurs after resuming the same dose despite maximal supportive measures
Croatian: Toksičnost 2. stupnja koja potraje ili se ponovno pojavi nakon primjene iste doze unatoč maksimalnim potpornim mjerama
English: The majority of the dose eliminated in faeces was metabolites.
Croatian: Većinu doze izlučene u feces činili su metaboliti.
English: Overall survival was not mature at the final PFS analysis (93 events observed across the two arms).
Croatian: Podaci za ukupno preživljenje nisu bili zreli u trenutku provođenja završne analize PFS-a (93 događaja opažena u obje skupine).
English: If you feel unusually tired or dizzy, take special care when driving or using machines.
Croatian: Ako imate omaglicu ili osjećate neuobičajen umor, budite posebno oprezni pri upravljanju vozilima ili radu sa strojevima.
English: Increased aminotransferases
Croatian: Povišene vrijednosti aminotransferaza