FrancophonIA/ELRC3.0 huggingface dataset:
English: Xermelo contains the active substance telotristat.
Croatian: Lijek Xermelo sadržava djelatnu tvar telotristat.
English: How is Xermelo used?
Croatian: Kako se Xermelo koristi?
English: 29 May 2019
Croatian: 29. svibnja 2019.
English: What is Radicava?
Croatian: Što je Radicava?
English: Doctors use this scale to rate how well patients can talk, breath, eat and perform other normal activities.
Croatian: Liječnici upotrebljavaju tu ljestvicu kako bi procijenili koliko dobro bolesnici mogu govoriti, disati, jesti i obavljati druge uobičajene aktivnosti.
English: ALS is a disease of the nervous system, where nerve cells in the brain and spinal cord that control voluntary movement gradually deteriorate, causing loss of muscle function and paralysis.
Croatian: ALS je bolest živčanog sustava kod koje živčane stanice u mozgu i leđnoj moždini koje kontroliraju dobrovoljno kretanje postupno odumiru, uzrokujući gubitak mišićne funkcije i paralizu.
English: Given the clear need for further evidence of Radicava's effectiveness, the Committee considered the possibility of a conditional approval, which would allow the company to provide more data at a later stage.
Croatian: S obzirom na jasnu potrebu za dodatnim dokazima o učinkovitosti lijeka Radicava, Odbor je razmatrao mogućnost davanja uvjetnog odobrenja čime bi se tvrtki omogućilo da u kasnijoj fazi dostavi više podataka.
English: Radicava was expected to be used to slow down the worsening of the disease in patients who can still perform normal daily activities.
Croatian: Očekivalo se da će se Radicava primjenjivati za usporavanje pogoršanja bolesti u bolesnika koji još mogu obavljati uobičajene svakodnevne aktivnosti.
English: However, the study involved only a small number of patients and there was not enough evidence of improvements in other important measures, such as those related to survival, breathing and muscle strength.
Croatian: Međutim, ispitivanjem je bio obuhvaćen samo malen broj bolesnika te nije bilo dovoljno dokaza o poboljšanju drugih važnih mjerila, kao što su ona povezana s preživljenjem, disanjem i mišićnom snagom.
English: The company informed the CHMP that the withdrawal does not have any impact on ongoing clinical trials.
Croatian: Tvrtka je obavijestila CHMP da povlačenje nema nikakvog učinka na klinička ispitivanja koja su u tijeku.
English: It was to be available as a solution for infusion (drip) into a vein.
Croatian: Trebao je biti dostupan kao otopina za infuziju (ukapavanje) u venu.
English: Withdrawal of the marketing authorisation application for Radicava (edaravone)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Radicava (edaravon)
English: The Committee considered the merits of such a study but had some objections, including the fact that the treatment for ALS had changed significantly over the past few years, rendering comparisons difficult.
Croatian: Odbor je razmotrio prednosti takvog ispitivanja, no imao je određene primjedbe, uključujući činjenicu da se liječenje ALS-a značajno promijenilo posljednjih nekoliko godina, zbog čega su usporedbe otežane.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was based on the Committee's provisional opinion on the study data.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da se povlačenje temelji na privremenom mišljenju Odbora o podatcima iz ispitivanja.
English: On 24 May 2019, Mitsubishi Tanabe Pharma GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Radicava intended for the treatment of amyotrophic lateral sclerosis (ALS).
Croatian: Mitsubishi Tanabe Pharma GmbH službeno je obavijestio Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Radicava za liječenje amiotrofične lateralne skleroze (ALS).
English: The company will continue with its ongoing compassionate use programmes pending discussions with national authorities that have already granted approval for compassionate use.
Croatian: Tvrtka će nastaviti sa svojim programima milosrdnog davanja lijekova koji su tijeku do okončanja rasprava s nacionalnim tijelima koja su već dala odobrenje za milosrdno davanje lijeka.
English: Furthermore, the CHMP noted important differences between the two groups which could have influenced the final results - such as the fact that a higher number of patients in the Radicava group had less severe disease.
Croatian: Nadalje, CHMP je primijetio važne razlike između dvije skupine, koje bi mogle utjecati na konačne rezultate, kao što je činjenica da je u skupini koja je uzimala lijek Radicava bio veći broj bolesnika u kojih je bolest bila manje ozbiljna?
English: The exact way Radicava works in patients with ALS is not known but it is thought to neutralise oxygencontaining molecules known as ‘free radicals', which have been linked to nerve damage in patients with ALS.
Croatian: Nije poznato kako točno djeluje lijek Radicava u bolesnika ALS-om, no smatra se da on neutralizira molekule koje sadržavaju kisik, pod nazivom „slobodni radikali”, i koje su povezane s oštećenjem živaca u bolesnika s ALS-om.
English: During the evaluation, the CHMP consulted a group of experts in the field to obtain their views on the study results, the proposed registry and the patient population that could potentially benefit from treatment with Radicava.
Croatian: Tijekom faze procjene CHMP se savjetovao sa skupinom stručnjaka iz tog područja kako bi saznao njihova mišljenja o rezultatima ispitivanja, predloženom registru i populaciji bolesnika koja bi mogla imati koristi od liječenja lijekom Radicava.
English: Radicava is a medicine that contains the active substance edaravone.
Croatian: Radicava je lijek koji sadržava djelatnu tvar edaravon.
English: At the time of the withdrawal, the Committee was of the opinion that, because of lack of proven effectiveness, the benefits of Radicava did not outweigh its risks.
Croatian: Odbor je u vrijeme povlačenja smatrao da, zbog izostanka potvrde o učinkovitosti, koristi od lijeka Radicava ne nadmašuju s njim povezane rizike.
English: How does Radicava work?
Croatian: Kako djeluje Radicava?
English: The CHMP was also concerned about the duration of any benefits from Radicava, noting that 24 weeks (a cut-off point in the main study) was too short and that data from the extension phase of the study were difficult to interpret.
Croatian: CHMP je isto tako izrazio zabrinutost zbog trajanja svih koristi od lijeka Radicava te je primijetio da su 24 tjedna (granična vrijednost u glavnom ispitivanju) prekratko razdoblje i da je bilo teško protumačiti podatke iz nastavka ispitivanja.
English: The study looked at how much patients' symptoms changed over 24 weeks, using a standard rating scale known as ‘ALS functional rating scale revised'
Croatian: U ispitivanju se provjeravalo koliko su se simptomi u bolesnika promijenili tijekom 24 tjedna primjenom standardne ljestvice ocjenjivanja pod nazivom
English: The company presented results from a main study of 137 patients with ALS who received either Radicava or placebo (a dummy treatment).
Croatian: Tvrtka je predstavila rezultate glavnog ispitivanja koje je obuhvatilo 137 bolesnika s ALS-om koji su primali lijek Radicava ili placebo (prividno liječenje).
English: What was Radicava expected to be used for?
Croatian: Za što se lijek Radicava trebao koristiti?
English: (ALSFRS-R).
Croatian: „revidirana ljestvica funkcionalnog ocjenjivanja za ALS” (ALSFRS-R).
English: The Committee noted that the main study did show significant improvements in ALSFRS-R scores in patients receiving Radicava compared with those receiving placebo.
Croatian: Odbor je primijetio da u glavnom ispitivanju nisu utvrđena značajna poboljšanja rezultata na ljestvici ALSFRS-R u bolesnika koji su primali lijek Radicava u usporedbi s onima koji su primali placebo.
English: At the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Radicava could not have been approved.
Croatian: U trenutku povlačenja CHMP je smatrao da postoje određeni razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Radicava.
English: Radicava was expected to be used to treat patients with amyotrophic lateral sclerosis (ALS).
Croatian: Lijek Radicava trebao se koristiti u liječenju amiotrofične lateralne skleroze (ALS).
English: When patients in the placebo group were later switched to Radicava there was no noticeable effect.
Croatian: Kasnije prebacivanje bolesnika iz skupine koja je uzimala placebo u skupinu koja je uzimala lijek Radicava nije imalo primjetnog učinka.
English: The company proposed a registry study whereby patients treated with Radicava could be compared with patients who received other treatments for ALS in the past.
Croatian: Tvrtka je predložila ispitivanje na temelju registra bolesnika u kojem bi se bolesnici liječeni lijekom Radicava mogli usporediti s bolesnicima koji su prethodno primali druga liječenja za ALS.
English: Further information on the orphan designation can be found here.
Croatian: Ovdje možete pronaći dodatne informacije o uvrštenju na popis lijekova za rijetke bolesti.
English: Radicava was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 19 June 2015 for ALS.
Croatian: Lijek Radicava uvršten je na popis lijekova za rijetke bolesti dana 19. lipnja 2015. za amiotrofičnu lateralnu sklerozu.
English: Blister (aluminium/PVC/PVDC)
Croatian: Za peroralnu primjenu Blister (alu/PVC/PVDC)
English: MA (EU) number
Croatian: Broj (EU) odobrenja (Novoizumljeno) ime
English: Strength Pharmaceutical form
Croatian: Jačina Farmaceutski oblik Put primjene
English: EU/1/18/1310/001
Croatian: EU/1/18/1310/001 Deferipron Lipomed 500 mg filmom obložena tableta
English: Immediate packaging
Croatian: Unutarnje pakiranje Veličina pakiranja
English: EU/2/14/170/0001 (2 tubes) EU/2/14/170/0002 (12 tubes) EU/2/14/170/0003 (20 tubes) EU/2/14/170/0004 (40 tubes)
Croatian: EU/2/14/170/0001 (2 tube) EU/2/14/170/0002 (12 tuba) EU/2/14/170/0003 (20 tuba) EU/2/14/170/0004 (40 tuba)
English: ATC-vet code: QS02CA90.
Croatian: ATCvet kod: QS02CA90.
English: Instructions for proper use:
Croatian: Upute za pravilnu uporabu:
English: Repeat the administration after 7 days.
Croatian: Ponovite primjenu nakon 7 dana.
English: Avoid accidental contact to the dog's eyes.
Croatian: Izbjegavajte slučajni doticaj s očima psa.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31/07/2014
Croatian: Datum prvog odobrenja: 31/07/2014
English: Store in a refrigerator (2 °C - 8 °C).
Croatian: Čuvati u hladnjaku (2 oC - 8 oC).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 dose
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 1 doza
English: Additional corticosteroid treatments should be avoided.
Croatian: Treba izbjegavati dodatna liječenja kortikosteroidima.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.2 g) contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 doza (1,2 g) sadrži:
English: Do not use in dogs with generalised demodicosis.
Croatian: Ne primjenjivati na psima s generaliziranom demodikozom.
English: This observation is attributed to presence of product and is not of clinical concern.
Croatian: Ovo opažanje pripisuje se prisutnosti proizvoda i nije od kliničkog značaja.
English: In case of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Croatian: U slučaju parazitskog otitisa, treba primijeniti odgovarajući akaricidni tretman.
English: Administer one tube per infected ear.
Croatian: Primijenite jednu tubu po jednom zaraženom uhu.
English: These findings are considered reversible.
Croatian: Ti se nalazi smatraju reverzibilnima.
English: 2 tubes 12 tubes 20 tubes 40 tubes
Croatian: 2 tube 12 tuba 20 tuba 40 tuba
English: These findings were not associated with clinical signs.
Croatian: Ti nalazi nisu povezani s kliničkim znakovima.
English: Introduce this flexible soft tip into the ear canal.
Croatian: Uvedite ovaj prilagodljivi mekani vrh u ušni kanal.
English: United Kingdom
Croatian: UJEDINJENO KRALJEVSTVO
English: Whenever possible the use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing.
Croatian: Kad god je to moguće, uporabu ovog veterinarsko-medicinskog proizvoda treba temeljiti na identifikaciji infektivnih organizama i testiranju osjetljivosti.
English: Oleic acid
Croatian: Oleinska kiselina
English: Open the tube by twisting the soft tip.
Croatian: Otvorite tubu okretanjem mekanog vrha.
English: To avoid this risk for the owners, it is recommended that this veterinary product is administered only by veterinarians or under their close supervision.
Croatian: Kako bi se izbjegao rizik za vlasnika, preporučuje se da ovaj veterinarsko-medicinski proizvod primjenjuju samo veterinari ili da se on primjenjuje uz njihov strogi nadzor.
English: Absorption occurred primarily during the first two to four days after administration, with low plasma concentrations (1 to 42 ng/ml) of active substances.
Croatian: Apsorpcija se prvenstveno dogodila tijekom prva dva do četiri dana nakon primjene s niskim plazmatskim koncentracijama (1 do 42 ng/ml) djelatnih tvari.
English: The maximum clinical response may not be seen until 21 days after the second administration.
Croatian: Maksimalni klinički odgovor možda neće biti vidljiv do 21. dana nakon druge primjene.
English: Apply the product into the ear canal by pressing it between two fingers.
Croatian: Primijenite proizvod u ušni kanal pritišćući tubu s dva prsta.
English: Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis.
Croatian: Florfenikol je bakteriostatski antibiotik koji djeluje inhibicijom sinteze proteina.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi poslije „EXP“.
English: The formulation dissolves in ear wax and is slowly eliminated from the ear mechanically.
Croatian: Formulacija se otapa u ušnoj smoli te se polako eliminira iz uha na mehanički način.
English: Clean the ears before the initial treatment is applied.
Croatian: Očistite uši prije početne terapije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija
English: Ask your veterinary surgeon, pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara kako odlagati veterinarsko-medicinske proizvode koji vam više nisu potrebni.
English: Accidental eye exposure may occur when the dog shakes its head during or just after administration.
Croatian: Do slučajnog izlaganja očiju može doći i kad pas protrese glavu tijekom ili neposredno nakon primjene.
English: Inflammation can increase the percutaneous absorption of veterinary medicinal products.
Croatian: Upala može povećati perkutanu apsorpciju veterinarsko medicinskog proizvoda.
English: If treatment with this product is discontinued, the ear canals should be cleaned before treatment with an alternative product is initiated.
Croatian: Ako se tretiranje ovim proizvodom prekine, ušne kanale treba očistiti prije početka tretiranja alternativnim proizvodom.
English: Use with precaution in dogs with suspected or confirmed endocrine disorder (i.e. diabetes mellitus; hypo- or hyper-thyroid disease, etc.).
Croatian: Proizvod oprezno koristite u pasa sa suspektnim ili potvrđenim endokrinim poremećajem (tj. šećernom bolešću (diabetes mellitus), hipotireozom ili hipertireozom itd.).
English: If hypersensitivity to any of the components occurs, the ear should be thoroughly washed.
Croatian: U slučaju preosjetljivosti na bilo koju komponentu, uho treba temeljito isprati.
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 8 µg/ml).
Croatian: Njegov spektar aktivnosti uključuje gram-pozitivne i gram-negativne bakterije uključujući Staphylococcus pseudintermedius (MIK90 od 8 µg/ml).
English: Cardboard box containing 2, 12, 20 or 40 tubes (each tube containing 2.05 g of product of which a single dose of 1.2 g can be extracted).
Croatian: Kartonska kutija koja sadrži 2, 12, 20 ili 40 tuba (svaka tuba sadrži 2,05 g veterinarsko-medicinskog proizvoda, od čega se može izvući pojedinačna doza od 1,2 g).
English: Terbinafine is an allylamine with a pronounced fungicidal activity.
Croatian: Terbinafin je alilamin s izrazitom fungicidnom aktivnosti.
English: Bacterial and fungal otitis is often secondary to other conditions.
Croatian: Bakterijski i gljivični otitis često je sekundarno stanje drugih poremećaja.
English: The finding was not correlated with pathological or clinical signs and was reversible.
Croatian: Nalaz nije bio u korelaciji s patološkim ili kliničkim znakovima te je bio reverzibilan.
English: These findings don't affect hearing and are reversible.
Croatian: Ti nalazi ne mogu utjecati na sluh te su reverzibilni.
English: If clinical signs develop, seek veterinary advice.
Croatian: Ako se pojave klinički znakovi, posavjetujte se s veterinarom.
English: Terbinafine has a different mode of action than azole antifungals, therefore there is no cross resistance with azole antifungals.
Croatian: Terbinafin ima drugačiji način djelovanja od azolnih antifungika pa stoga ne postoji križna otpornost s azolnim antifungicima.
English: Additionally, dogs showed slightly elevated red blood cell count, hematocrit, total protein, albumin and alanine aminotransferase.
Croatian: Pored toga, kod pasa je uočen blagi porast eritrocita, hematokrita, ukupnih proteina, albumina i alanin aminotransferaze.
English: Systemic absorption of all active substances was determined in multiple-dose studies after placing the veterinary medicinal product into both ear canals of healthy mixed breed dogs.
Croatian: Sustavna apsorpcija svih djelatnih tvari utvrđena je u studijama s više doza nakon aplikacije veterinarsko-medicinskog proizvoda u oba ušna kanala zdravih pasa mješanca.
English: It is recommended not to repeat ear cleaning until 21 days after the second administration of the product.
Croatian: Preporučuje se ne ponavljati čišćenje uha sve do 21 dana nakon druge primjene proizvoda.
English: The safety of the product has not been established in dogs less than 2 months of age and weighing less than 1.4 kg.
Croatian: Neškodljivost proizvoda nije bila utvrđena u pasa mlađih od 2 mjeseca i koji teže manje od 1,4 kg.
English: Due to the high antimicrobial concentrations achieved in the ear canal and the multifactorial nature of otitis externa, in vitro susceptibility may not be directly correlated with clinical success.
Croatian: Zbog visokih antimikrobnih koncentracija postignutih u ušnom kanalu i multifaktorijalne prirode vanjskog otitisa, in vitro osjetljivost možda neće biti izravno povezana s kliničkim uspjehom.
English: There were no clinical signs associated with unilateral vesicle formation within the epithelium of the tympanic membrane (also observed after six administrations, one week apart, of 1 tube per ear or 2 tubes per dog), unilateral mucosal ulceration in the lining of the middle ear cavity, or decrease in serum cortisol response below normal reference range in ACTH stimulation testing.
Croatian: Nije bilo kliničkih znakova povezanih s unilateralnom formacijom vezikula unutar epitela timpaničke membrane (uočeno također nakon šest primjena, s razmakom od tjedan dana, jedna tuba po svakom uhu ili 2 tube po psu), unilateralnom ulceracijom sluznice u ovojnici šupljine srednjeg uha ili smanjenom reakcijom na serumski kortizol ispod normalno referentnog raspona u testiranju stimulacije ACTH.
English: The safety of the product has not been established in dogs less than 2 months of age or weighing less than 1.4 kg.
Croatian: Neškodljivost proizvoda nije bila utvrđena u pasa mlađih od 2 mjeseca ili u onih koji teže manje od 1,4 kg.
English: Auricular administration of five times the recommended dose, one week apart, for 5 consecutive weeks (a total six administrations of 5 tubes per ear or 10 tubes per dog) to mixed breed dogs weighing 10 to 14 kg resulted in clinical signs of wetness of the inner and outer pinna (attributed to presence of the product).
Croatian: Aurikularna primjena doza pet puta većih od preporučenih, u razmaku od tjedan dana, tijekom pet uzastopnih tjedana (ukupno šest primjena 5 tuba po uhu ili 10 tuba po psu), psima mješancima koji teže od 10 do 14 kg, rezultirala je kliničkim znakovima: vlažnost unutarnje i vanjske uške (pripisano prisutnosti proizvoda).
English: Argenta Dundee Limited, Kinnoull Road, Dunsinane Industrial Estate, Dundee DD2 3XR, UNITED KINGDOM
Croatian: Argenta Dundee Limited, Kinnoull Road, Dunsinane Industrial Estate, Dundee DD2 3XR, UJEDINJENO KRALJEVSTVO
English: Betamethasone is known to be teratogenic in laboratory species.
Croatian: Poznato je da betametazon djeluje teratogeno na laboratorijskim vrstama.
English: Elanco France S.A.S., 26 Rue de la Chapelle, 68330 Huningue, France
Croatian: Elanco France S.A.S., 26 Rue de la Chapelle, 68330 Huningue, Francuska
English: In clinical trials, saline only was used for ear cleaning.
Croatian: U kliničkim ispitivanjima za čišćenje ušiju korištena je samo fiziološka otopina.
English: Decreased cortisol levels were observed after product instillation in tolerance studies (before and after ACTH stimulation), indicating that betamethasone is absorbed and enters the systemic circulation.
Croatian: Nakon primjene proizvoda u studijama podnošljivosti uočene su snižene razine kortizola (prije i nakon stimulacije ACTH) ukazujući na to da se betametazon apsorbira i ulazi u sustavni krvotok.
English: After application, the base of the ear may be massaged briefly and gently to facilitate even distribution of the veterinary medicinal product into the ear canal.
Croatian: Nakon primjene, bazu uha masirajte kratko i lagano kako bi se veterinarsko-medicinski proizvod jednakomjerno rasporedio u ušnom kanalu.
English: The extent of percutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Croatian: Stupanj perkutane apsorpcije topikalno primijenjenih proizvoda određuje se mnogim čimbenicima koji uključuju i integritet epidermalne barijere.
English: Do not use in pregnant or breeding animals.
Croatian: Ne primjenjivati na gravidnim ili rasplodnim životinjama.
English: In case of accidental skin contact, wash exposed skin thoroughly with water.
Croatian: U slučaju nehotičnog doticaja s kožom, izloženi dio kože temeljito operite vodom.
English: Do not use if the eardrum is perforated.
Croatian: Ne primjenjivati ako je bubnjić perforiran.
English: Pharmacotherapeutic group: Otologicals - Corticosteroids and anti-infectives in combination.
Croatian: Farmakoterapijska skupina: otologici - kombinacija kortikosteroida i antiinfektiva.
English: It selectively inhibits the early synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis (MIC90 of 2 µg/ml).
Croatian: Selektivno inhibira rane stadije sinteze ergosterola koji je esencijalna komponenta membrane kvasaca i gljivica uključujući Malassezia pachydermatis (MIK90 od 2 µg/ml).
English: In case of accidental ocular exposure, flush the eyes thoroughly with water for 10 to 15 minutes.
Croatian: U slučaju nehotičnog izlaganja očiju, oči temeljito ispirite vodom 10 do 15 minuta.
English: Florfenicol:
Croatian: Florfenikol (florfenicolum):
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Tube
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA