FrancophonIA/ELRC3.0 huggingface dataset:
English: The claim of effectiveness relied on data from a subgroup of patients from a main study which, overall, failed to convincingly show the effectiveness of Onzeald.
Croatian: Tvrdnja o učinkovitosti temelji se na podatcima za podskupinu bolesnika iz glavnog ispitivanja, no ti podatci zajedno nisu uspjeli uvjerljivo dokazati učinkovitost lijeka Onzeald.
English: Refusal of the marketing authorisation for Onzeald (etirinotecan pegol)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Onzeald (etirinotekan pegol)
English: The active substance in Onzeald, etirinotecan pegol, consists of irinotecan (a cancer medicine that belongs to the group ‘topoisomerase inhibitors') that has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Croatian: Djelatna tvar u lijeku Onzeald, etirinotekan pegol, sadržava irinotekan (lijek protiv raka koji pripada skupini „inhibitora topoizomeraze”) koji je prošao postupak „pegilacije” (vezanje za kemijski spoj polietilen glikol).
English: Because it is pegylated in etirinotecan pegol, the medicine is removed from the body at a slower rate, allowing the medicine to be given less often.
Croatian: Budući da je irinotekan u etirinotekan pegolu pegiliran, njegovo uklanjanje iz tijela je usporeno, što omogućava rjeđe davanje lijeka.
English: Irinotecan blocks topoisomerase I, an enzyme that is involved in copying cell DNA, which is needed to make new cells.
Croatian: Irinotekan blokira enzim naziva topoizomeraza I, koji je uključen u kopiranje stanične DNK, koja je potrebna za stvaranje novih stanica.
English: Onzeald is a cancer medicine that contains the active substance etirinotecan pegol.
Croatian: Onzeald je lijek protiv raka koji sadrži djelatnu tvar etirinotekan pegol.
English: On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Onzeald, intended for the treatment of advanced breast cancer that has spread to the brain.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje izdavanja odobrenja za stavljanje u promet lijeka Onzeald, koji je namijenjen liječenju uznapredovalog raka dojke koji se proširio na mozak.
English: Therefore, the CHMP was of the opinion that the study did not provide enough evidence on the benefits of Onzeald and recommended that the marketing authorisation be refused.
Croatian: Stoga je CHMP smatrao da ispitivanjem nije izneseno dovoljno dokaza o koristima lijeka Onzeald te je preporučio odbijanje izdavanja odobrenja za stavljanje u promet.
English: It was to be available as a powder to be made into a solution for infusion (drip) into a vein.
Croatian: Lijek je trebao biti dostupan u obliku praška od kojeg se priprema otopina za intravensku infuziju (drip).
English: Onzeald was expected to be used to treat adults with advanced breast cancer that had spread to the brain and other parts of the body and who have already received other treatments.
Croatian: Onzeald se trebao koristiti za liječenje uznapredovalog raka dojke koji se proširio na mozak i druge dijelove tijela u odraslih osoba koje su već bile podvrgnute drugim oblicima liječenja.
English: The CHMP considered that the benefit of Onzeald in the treatment of advanced breast cancer that had spread to the brain and other parts of the body had not been sufficiently demonstrated.
Croatian: CHMP je smatrao da koristi lijeka Onzeald za liječenje raka dojke koji se proširio na mozak i druge dijelove tijela nisu dokazane u dovoljnoj mjeri.
English: Both groups had off periods of about 36-37% at the start of the study.
Croatian: Obje su grupe imale razdoblja isključenosti od otprilike 36-37% na početku ispitivanja.
English: Numient levodopa / carbidopa
Croatian: Numient levodopa / karbidopa
English: Patients who took placebo had an average improvement of 0.6 points.
Croatian: Bolesnici koji su primili placebo imali su prosječno poboljšanje od 0,6 bodova.
English: Other information about Numient
Croatian: Ostale informacije o lijeku Numient
English: The full EPAR and risk management plan summary for Numient can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Numient nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Numient capsules are taken with a glass of water.
Croatian: Kapsule lijeka Numient uzimaju se sa čašom vode.
English: These types of capsules are known as modifiedrelease capsules.
Croatian: Ovi tipovi kapsula su poznati kao kapsule s modificiranim otpuštanjem.
English: Patients who have difficulty swallowing can have the content of the capsules sprinkled on soft food such as apple sauce, yoghurt or pudding.
Croatian: Bolesnici koji imaju poteškoća s gutanjem mogu posipati sadržaj kapsula na mekanu hranu poput soka od jabuke, jogurta ili pudinga.
English: What measures are being taken to ensure the safe and effective use of Numient?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Numient?
English: The starting dose for patients who have not previously taken levodopa is one capsule containing 95 mg of levodopa and 23.75 mg of carbidopa, three times daily for the first three days.
Croatian: Početna doza za bolesnike koji prethodno nisu uzimali tvar levodopa je jedna kapsula koja sadrži 95 mg levodopa i 23,75 mg karbidopa, tri puta dnevno tijekom prva tri dana.
English: The doctor may then increase the dose depending on how the condition responds to treatment.
Croatian: Liječnik zatim može povećati dozu ovisno o tome kako bolesnik reagira na terapiju.
English: This study looked at how well the treatments reduced the time when patients have more difficulty moving about, called ‘off periods'.
Croatian: Ovo je ispitivanje istražilo koliko su dobro terapije skratile vrijeme u kojem su bolesnici imali više poteškoća prilikom kretanja, koji se zovu"razdoblja isključenosti".
English: It is not intended to provide practical advice on how to use Numient.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Numient.
English: What is Numient and what is it used for?
Croatian: Što je Numient i za što se koristi?
English: The patient should then swallow the food immediately without chewing.
Croatian: Bolesnici trebaju zatim progutati hranu bez žvakanja.
English: Numient is available as capsules to be taken by mouth.
Croatian: Numient je dostupan kao kapsule koje se uzimaju na usta.
English: They can be taken with or without food, but should not be taken at the same time as high protein meals, which can reduce absorption.
Croatian: Kapsule se mogu uzimati sa ili bez hrane, no ne smiju se uzimati istovremeno s obrocima bogatima bjelančevina, jer to smanjuje apsorpciju.
English: Why is Numient approved?
Croatian: Zašto je Numient odobren?
English: The combination of levodopa and carbidopa is used in other medicines for Parkinson's disease.
Croatian: Kombinacija levodopa i karbidopa koristi se i u drugim lijekovima za liječenje Parkinsonove bolesti.
English: After 30 weeks, patients taking Numient had their symptoms improve by an average of between 11.7 and 14.9 points (depending on dose) on a standard symptom scale (Unified Parkinson's Disease Rating Scale, UPDRS Part II and Part III).
Croatian: Nakon 30 tjedana, kod bolesnika koji su uzimali Numient simptomi su se poboljšali prosječno između 11,7 i 14,9 bodova (ovisno o dozi) na standardnoj ljestvici simptoma (unificirana skala ocjene Parkinsonove bolesti, UPDRS dijelovi II i dio III).
English: The most frequent side effects with Numient are nausea in (12% of patients), dizziness, headache and involuntary movements (each occurring in 8% of patients), and insomnia (in 6% of patients).
Croatian: Najčešće nuspojave lijeka Numient su mučnina (u 12% bolesnika), vrtoglavica, glavobolja i nenamjerni pokreti (od kojih je svaki nastupio u 8% bolesnika), te nesanica (u 6% bolesnika).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Numient's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Numient nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: After 13 weeks, patients taking Numient had off periods of about 24% of their waking hours compared with 30% of waking hours in patients taking the comparator medicine.
Croatian: Nakon 13 tjedana, bolesnici koji su uzimali Numient imali su razdoblja isključenosti od otprilike 24% u odnosu na njihova razdoblja hodanja u usporedbi s 30% satova hodanja u bolesnika koji su uzimali usporedni lijek.
English: This is a summary of the European public assessment report (EPAR) for Numient.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Numient.
English: A risk management plan has been developed to ensure that Numient is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Numient.
English: What are the risks associated with Numient?
Croatian: Koji su rizici povezani s lijekom Numient?
English: It must also not be used in patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients with a history of certain medical conditions.
Croatian: Ne smije se koristiti u bolesnika koji uzimaju lijekove poznate kao inhibitori neselektivne monoamin oksidaze (MAO) ili u bolesnika s određenim zdravstvenim stanjima.
English: In a study of 381 patients with early stage Parkinson's disease, Numient at various doses was more effective at improving symptoms than placebo (a dummy treatment).
Croatian: U ispitivanju provedenom na 381 bolesnika s ranim stadijem Parkinsonove bolesti, Numient u različitim dozama bio je djelotvorniji u poboljšavanju simptoma od placeba (prividno liječenje).
English: It contains the active substances levodopa and carbidopa.
Croatian: Sadrži djelatne tvari levodopa i karbidopa.
English: More serious side effects include bleeding from the gut and allergic reactions, and have been reported uncommonly.
Croatian: Ozbiljnije nuspojave uključuju krvarenje iz crijeva i alergijske reakcije, te su prijavljene kao rijetke nuspojave.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Numient, 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 lijek Numient nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Studies show that Numient is effective at reducing symptoms in patients with early and late stage Parkinson's disease.
Croatian: Ispitivanja su pokazala da je Numient djelotvoran u smanjivanju simptoma u bolesnika u ranom i kasnom stadiju Parkinsonove bolesti.
English: Another benefit is the way the active substances are formulated in Numient, which helps maintain more steady levodopa levels.
Croatian: Druga korist je način na koji se djelatne tvari formuliraju u lijeku Numient, što pomaže pri održavanju stabilnijih koncentracija levodopa.
English: For patients already taking levodopa, the doctor will determine the dose of Numient based on their current treatment.
Croatian: U slučaju bolesnika koji uzimaju tvar levodopa, liječnik utvrđuje dozu lijeka Numient na temelju njihove postojeće terapije.
English: In patients with Parkinson's disease, the cells in the brain that produce dopamine, a neurotransmitter important for controlling movement, begin to die and the amount of dopamine in the brain decreases.
Croatian: U bolesnika s Parkinsonovom bolešću, stanice mozga koje proizvode dopamin, neurotransmiter koji je važan za kontroliranje pokreta, počinju odumirati te se smanjuje količina dopamina u mozgu.
English: Numient is used in adults to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking and muscular stiffness and slows down movement.
Croatian: Numient se koristi za liječenje odraslih sa simptomima Parkinsonove bolesti, progresivne bolesti mozga koja uzrokuje treskavicu, usporene pokrete i ukočenost mišića.
English: 95 mg/23.75 mg, 145 mg/36.25 mg, 195 mg/48.75 mg and 245 mg/61.25 mg. For further information on how to use Numient, see the summary of product characteristic (also part of the EPAR).
Croatian: Numient se izdaje samo na liječnički recept i dostupan je u sljedećim jačinama: 95 mg/23,75 mg; 145 mg/36,25 mg; 195 mg/48,75 mg i 245 mg/61,25 mg.
English: In Numient, a portion of the active substances is released immediately, while the remaining is released gradually, leading to more steady levodopa levels.
Croatian: Kod lijeka Numient, udio djelatnih tvari se otpušta odmah, dok se preostali dio postepeno otpušta, što rezultira stabilnijim koncentracijama levodopa.
English: For practical information about using Numient, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Numient bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: Numient must not be used in patients with narrow angle glaucoma (an eye disorder) or pheochromocytoma (a tumour of the adrenal glands).
Croatian: Numient se ne smije koristiti u bolesnika s glaukomom suženoga kuta (poremećajem oka) ili feokromokitomijom (tumorom nadbubrežne žlijezde).
English: For more information about treatment with Numient, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Numient pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: What benefits of Numient have been shown in studies?
Croatian: Koje su koristi lijeka Numient utvrđene u ispitivanjima?
English: Numient contains levodopa which converts into dopamine in the brain and helps to restore dopamine levels.
Croatian: Numient sadrži tvar levodopa koji se pretvara u dopamin u mozgu i pomaže pri održavanju koncentracija dopamina.
English: How is Numient used?
Croatian: Kako se Numient koristi?
English: The carbidopa in Numient stops the levodopa from converting into dopamine while still in the general circulation, before it has reached the brain.
Croatian: Karbidopa u lijeku Numient sprječava tvar levodopa da se pretvori u dopamin dok se nalazi u krvi, prije nego dođe u mozak.
English: How does Numient work?
Croatian: Kako djeluje Numient?
English: A second study compared Numient with another treatment containing levodopa and carbidopa in 393 patients with advanced Parkinson's disease.
Croatian: Drugo je ispitivanje usporedilo Numient s drugom terapijom koja je sadržavala tvari levodopa i karbidopa.
English: These local reactions gradually reduce and disappear without need for treatment.
Croatian: Te lokalne reakcije se postepeno smanjuju i nestaju bez potrebe za tretmanom.
English: No available data.
Croatian: Nema dostupnih podataka.
English: Keep the bottle in the outer carton in order to protect from light.
Croatian: Držite bočicu u vanjskom kartonu radi zaštite od svjetla.
English: Revaccination: 12 months after vaccination.
Croatian: Revakcinacija: 12 mjeseci nakon vakcinacije.
English: ATCvet code: QI08AA
Croatian: ATCvet kod: QI08AA
English: Date of first authorisation: 22 September 2016
Croatian: Datum prvog odobrenja: 22.09.2016
English: Onset of immunity: 1 week.
Croatian: Nastanak imunosti: 1 tjedan.
English: Mineral oil
Croatian: Mineralno ulje
English: Overdose (symptoms, emergency procedures, antidotes): No available data.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): Nema dostupnih podataka.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako primijetite bilo kakve nuspojave, uključujući i one koje nisu nabrojene na listiću uz ovo pakiranje, ili mislite da lijek nije djelovao, molimo obavijestite veterinara.
English: Accidental injection is dangerous.
Croatian: Nehotično injiciranje je opasno.
English: Each dose of 0.5 ml contains:
Croatian: Jedna doza od 0,5 ml sadrži:
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne koristiti ovaj veterinarsko medicinski proizvod nakon isteka roka valjanosti naznačenog na etiketi (EXP).
English: The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated.
Croatian: Cjepivo pruža zaštitu samo protiv RHDV2, unakrižna zaštita protiv klasičnog virusa RHDV nije utvrđena.
English: Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Water for injections
Croatian: Dinatrijev fosfat dodekahidrat Kalijev dihidrogenfosfat Voda za injekcije
English: Pharmacotherapeutic group: Inactivated viral vaccines for Leporidae, inactivated viral vaccine for rabbits.
Croatian: Farmakoterapijska skupina: Inaktivirana virusna cjepiva za Leoporidae, inaktivirano virusno cjepivo za kuniće.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoje od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
English: Incompatibilities: Do not mix with any other veterinary medicinal products.
Croatian: Inkompatibilnosti: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: Shelf life after first opening the immediate packaging: Use immediately.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: odmah upotrijebiti.
English: Vaccination of rabbits induced the production of hemagglutination inhibition antibodies that persisted for at least 12 months.
Croatian: Vakcinacija kunića uzrokovala je stvaranje antitijela za inhibiciju hemaglutinacije, postojanih tijekom najmanje 12 mjeseci.
English: Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: LABORATORIOS HIPRA, S.A.
English: Sorbitan mono-oleate Polysorbate 80
Croatian: Sorbitan monooleat Polisorbat 80
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Croatian: Nehotična injekcija/samo injiciranje može prouzročiti jaku bol i oticanje, naročito ako se injicira u zglob ili prst, a u rijetkim slučajevima može rezultirati gubitkom zahvaćenog prsta ukoliko nije pružena hitna medicinska pomoć.
English: Vial label (1, 10 or 40 doses)
Croatian: Bočice (1, 10 ili 40 doza)
English: EXP {month/year} Once broached use immediately.
Croatian: EXP {mjesec/godina} Načeto cjepivo odmah upotrijebiti.
English: Detailed information on this veterinary medicinal product us available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s propisima o zbrinjavanju otpada,.
English: Before use allow the vaccine to reach room temperature.
Croatian: Prije primjene cjepivo je potrebno zagrijati na sobnu temperaturu.
English: A transient temperature increase slightly above 40 ºC might very commonly occur between two or three days following vaccination.
Croatian: Vrlo je česta pojava prolaznog porasta temperature malo iznad 40 ºC dva do tri dana nakon cijepljenja.
English: La Selva, 135 17170 Amer SPAIN
Croatian: La Selva, 135 17170 Amer ŠPANJOLSKA
English: Shake well before administration.
Croatian: Dobro protresti prije primjene.
English: Pregnant does should be handled with special care to avoid stress and risk of abortion
Croatian: O skotnim ženkama kunića potrebno je brinuti s najvećom pažnjom kako bi se izbjegao stres i rizik od abortusa.
English: Administer 1 dose (0.5 ml) of the veterinary medicinal product to rabbits from the age of 30 days by subcutaneous injection in the lateral thoracic wall.
Croatian: Primijenite 1 dozu (0,5 ml) veterinarsko-medicinskog proizvoda na kunićima starijim od 30 dana injekcijom pod kožu lateralnog torakalnog zida.
English: Laboratory studies in pregnant doe in the last third of gestation have not been produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Croatian: Laboratorijska istraživanja na ženkama kunića u zadnjoj trećini graviditeta nisu donijela nikakve dokaze o teratogenim niti foetotoksičnim ili maternotoksičnim učincima
English: Whitish emulsion.
Croatian: Bjelkasta emulzija.
English: This slight temperature increase resolves spontaneously without treatment by day 5 post vaccination.
Croatian: Blago povišenje tjelesne temperature prestaje spontano, do 5 dana nakon cijepljenja, bez liječenja.
English: Thiomersal: ………………..0.05 mg
Croatian: Tiomersal: ………………0,05 mg
English: Mineral oil: ………………..104.125 mg
Croatian: Mineralno ulje: ………………104,125 mg
English: 1 x 40 doses (20 ml).
Croatian: 1 x 40 doza (20 ml).
English: Duration of immunity: 12 months demonstrated by challenge
Croatian: Trajanje imunosti: dokazano ispitivanjem kroz 12 mjeseci.
English: Expert, prompt, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Croatian: HITNO je potreban stručni kirurški pregled koji može zahtijevati preventivnu inciziju i ispiranje injiciranog područja, napose u području jagodice prsta ili tetiva.
English: To stimulate active immunity against the rabbit haemorrhagic disease type 2 virus (RHDV2).
Croatian: Za poticanje aktivne imunosti protiv virusa hemoragijske bolesti kunića tipa 2 (RHDV2).
English: Special precautions for use in animals Vaccination is recommended where RHDV2 is epidemiologically relevant.
Croatian: Cijepljenje se preporučuje u onim područjima gdje je RHDV2 epidemiološki značajan.
English: Lethargy and/or inappetence may be observed very rarely in the first 48 hours after injection, based on post-authorisation pharmacovigilance reporting.
Croatian: Prema farmakovigilancijskim izvješćima nakon odobrenja, u prvih se 48 sati nakon davanja injekcije vrlo rijetko mogu uočiti iscrpljenost i/ili nedostatak apetita.