FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition updates on recruitment should be submitted within the PSURs.
Croatian: Uz to, unutar periodičkih izvješća o neškodljivosti lijeka(PSURevi) treba podnijeti ažuriranja o prikupljanju sudionika.
English: The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Ne smije se primjenjivati u sljedećim stanjima:
English: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and herpes simplex I virus thymidine kinase (HSV-TK Mut2)
Croatian: Alogene T-stanice genetski modificirane retrovirusnim vektorom koji kodira skraćeni oblik ljudskog receptora za faktor rasta živaca niskog afiniteta (ΔLNGFR) i timidin kinazu virusa herpes simplex tip 1 (HSV-TK Mut2)
English: o The room requirements for Zalmoxis administration o Storage, transport and thawing of Zalmoxis bag o Surveillance of Zalmoxis efficacy (Immune reconstitution - IR)
Croatian: o zahtjeve koji se odnose prostoriju u kojoj se primjenjuje lijek Zalmoxis o skladištenje, prijevoz i odmrzavanje vrećice lijeka Zalmoxis o nadzor djelotvornosti lijeka Zalmoxis (imunološke rekonstitucije) Radi praćenja imunološke rekonstitucije, potrebno je jednom tjedno provoditi kvantifikacijsku analizu CD3+ stanica tijekom prvog mjeseca nakon primjene lijeka Zalmoxis.
English: The active substance consists of allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2).
Croatian: Djelatna se tvar sastoji od alogenih T-stanica genetski modificiranih retrovirusnim vektorom koji kodira skraćeni oblik ljudskog receptora za faktor rasta živaca niskog afiniteta (ΔLNGFR) i timidin kinazu virusa herpes simplex tip 1 (HSV-TK Mut2).
English: o Onset of GVHD requiring systemic immunosuppressive therapy o Ongoing systemic immunosuppressive therapy or administration of granulocyte colony stimulating factor (G-CSF) after haploidentical hematopoietic stem-cell transplantation
Croatian: Bolesnicima se ne smije primijeniti Zalmoxis u slučaju: o pojave GvHD-a koja zahtijeva sustavnu terapiju imunosupresivima o sustavne terapije imunosupresivima ili primjene čimbenika stimulacije kolonije granulocita
English: HOW ZALMOXIS IS GIVEN TO YOU
Croatian: KAKO SE DAJE ZALMOXIS
English: STATEMENT OF ACTIVE SUBSTANCE(S) The bag contains a volume of 10-100 mL of frozen dispersion at a concentration of 5-20 x 106 cells/mL
Croatian: Vrećica sadrži volumen od 10-100 ml smrznute disperzije pri koncentraciji od 5-20 x 106 stanica/ml
English: EXPIRY DATE Expiry date:
Croatian: ROK VALJANOSTI Rok valjanosti:
English: Store in liquid nitrogen vapour.
Croatian: Čuvati u pari tekućeg dušika.
English: NAME OF THE MEDICINAL PRODUCT
Croatian: FARMACEUTSKI PODACI
English: Pregnancy and breast-feeding
Croatian: Poremećaji jetre i žuči
English: MolMed S.p.A.
Croatian: 106 stanica/ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
Croatian: 2.1 Opći opis
English: Other medicines and Zalmoxis
Croatian: Drugi lijekovi i Zalmoxis Nisu provedena ispitivanja interakcija.
English: What is Blectifor?
Croatian: Što je Blectifor?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was doing so for commercial reasons.
Croatian: U dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da to čini iz komercijalnih razloga.
English: Furthermore, the proposed indication was not supported by the provided literature, and the target population was considered not sufficiently characterised.
Croatian: Osim toga, dostavljena literatura ne potvrđuje predloženu indikaciju, a smatra se da ciljna populacija nije dovoljno okarakterizirana.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 March 2017 EMA/188385/2017 EMEA/H/C/004100
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24. ožujka 2017.
English: It was to be available as a solution for injection, which can also be given by mouth.
Croatian: Trebao je biti stavljen na tržište u obliku otopine za injekciju koja se može primjenjivati i kroz usta.
English: Another concern was that the applicant did not demonstrate the so-called well-established use (systematic and documented use in the EU for more than 10 years) of caffeine citrate for the prevention of bronchopulmonary dysplasia.
Croatian: Dodatni razlog za zabrinutost predstavlja činjenica da podnositelj zahtjeva nije dokazao tzv. provjerenu medicinsku uporabu (sustavnu i dokumentiranu uporabu u EU-u više od 10 godina) kofeincitrata za sprječavanje bronhopulmonalne displazije.
English: Additionally, the facility designated to test the stability of Blectifor was not certified to comply with good manufacturing practices (GMP).
Croatian: Nadalje, ustanova koja je trebala ispitati stabilnost lijeka Blectifor nema potvrdu o usklađenosti s dobrom proizvođačkom praksom (GMP).
English: Withdrawal of the marketing authorisation application for Blectifor (caffeine citrate)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Blectifor (kofeincitrat)
English: premature babies.
Croatian: nedonoščadi.
English: Blectifor is a medicine that contains the active substance caffeine citrate.
Croatian: Blectifor je lijek koji sadrži djelatnu tvar kofeincitrat.
English: The company presented data from the published scientific literature mainly on the use of caffeine citrate for the treatment of primary apnoea in premature babies; several articles also provided data on the development of bronchopulmonary dysplasia in these patients.
Croatian: Tvrtka je dostavila podatke iz objavljene znanstvene literature koji se uglavnom odnose na primjenu kofeincitrata za liječenje primarne apneje kod nedonoščadi; u nekoliko su članaka bili navedeni podaci o razvoju bronhopulmonalne displazije kod tih bolesnika.
English: This leads to difficulty breathing and poor growth, and later in life can result in frequent infections of the airways and long-term lung problems.
Croatian: To dovodi do problema s disanjem i usporenog rasta, što u kasnijim fazama života može imati kao posljedicu česte upale dišnih putova i dugoročne probleme s plućima.
English: On 9 March 2017, Viridian Pharma Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Blectifor, for the prevention of bronchopulmonary dysplasia.
Croatian: Viridian Pharma Ltd. službeno je obavijestio Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za izdavanje odobrenja za stavljanje u promet lijeka Blectifor za sprječavanje bronhopulmonalne displazije.
English: In these babies, the continuous high pressure and high concentration of the oxygen supplied through mechanical ventilation may cause inflammation and injury to the lungs and prevent normal development of the alveoli (air sacs in the lungs).
Croatian: Stalna izloženost visokom tlaku i visokoj koncentraciji kisika stvorenog mehaničkom ventilacijom kod takve djece može uzrokovati upalu i ozljedu pluća te spriječiti normalni razvoj alveola (plućnih mjehurića).
English: The active substance in Blectifor, caffeine citrate, is a stimulant of the nervous system and is currently authorised in the EU as Peyona for the treatment of a breathing disorder called primary apnoea in
Croatian: Djelatna tvar u lijeku Blectifor, kofeincitrat, djeluje kao stimulans živčanog sustava te je trenutačno odobren u EU-u kao lijek Peyona za liječenje poremećaja disanja koji se naziva primarna apneja kod
English: The Committee considered that the role of caffeine citrate in the prevention of the disease had not been sufficiently demonstrated, and no definite conclusion on the effect of caffeine citrate for the prevention of bronchopulmonary dysplasia could be drawn.
Croatian: Odbor je smatrao da uloga kofeincitrata u sprječavanju bolesti nije dovoljno dokazana te da se ne može donijeti konačan zaključak o utjecaju kofeincitrata na sprječavanje bronhopulmonalne displazije.
English: In addition, caffeine citrate may also have other effects in the lungs, such as reducing inflammation, which are expected to prevent the damage that leads to bronchopulmonary dysplasia.
Croatian: Osim toga, kofeincitrat može djelovati na pluća i na druge načine, kao što je smanjenje upale, što bi trebalo spriječiti oštećenja koja dovode do bronhopulmonalne displazije.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that, based on the data submitted by the company, Blectifor could not have been approved for the prevention of bronchopulmonary dysplasia.
Croatian: Na temelju pregledanih podataka u trenutku povlačenja, CHMP je smatrao da postoji nekoliko razloga za zabrinutost te je njegovo privremeno mišljenje bilo da na temelju podataka koje je dostavila tvrtka nije moguće dati odobrenje za lijek Blectifor za sprječavanje bronhopulmonalne displazije.
English: In the prevention of bronchopulmonary dysplasia, caffeine citrate is expected to act mainly by stimulating the part of the brain that controls breathing, which is thought to help babies breathe on their own and reduce the time spent on mechanical ventilation.
Croatian: U sprječavanju bronhopulmonalne displazije kofeincitrat trebao bi djelovati na način da stimulira dio mozga koji upravlja disanjem jer se vjeruje da to pomaže djeci da samostalno dišu i smanjuje vrijeme provedeno na mehaničkoj ventilaciji.
English: What was Blectifor expected to be used for?
Croatian: Za što se lijek Blectifor trebao koristiti?
English: Blectifor was expected to be used to prevent bronchopulmonary dysplasia, a lung disease affecting premature babies who have been on prolonged mechanical ventilation (using a machine that supplies oxygen to support breathing).
Croatian: Blectifor se trebao koristiti za sprječavanje bronhopulmonalne displazije, bolesti pluća od koje obolijeva nedonoščad koja je dugo vremena provela na mehaničkoj ventilaciji (upotreba stroja za opskrbljivanje kisikom kojim se potiče disanje).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Blectifor.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao da tvrtka nije dostavila dostatne podatke kojima bi potkrijepila zahtjev za lijek Blectifor.
English: How does Blectifor work?
Croatian: Kako djeluje Blectifor?
English: Withdrawal of the marketing authorisation application for Blectifor (caffeine citrate) EMA/188385/2017
Croatian: EMA/188385/2017
English: Blectifor was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 April 2014 for the prevention of bronchopulmonary dysplasia.
Croatian: Dana 11. travnja 2014. lijek Blectifor označen je kao lijek za liječenje rijetkih bolesti koji se primjenjuje u sprječavanju bronhopulmonalne displazije.
English: 56 ampoules + 1 administration device
Croatian: 56 ampula x 1 naprava za raspršivanje
English: 170 mg Nebuliser solution Inhalation use ampoule (LDPE)
Croatian: 170 mg Otopina za nebulizator
English: Immediate Packaging
Croatian: Sastav Veličina pakovanja
English: (Reference is made to the pictogram of a dog in section 1).
Croatian: (Referenca je na piktogram psa u odjeljku 1.)
English: Date of first authorisation: 10/12/2019.
Croatian: Datum prvog odobrenja:10/12/2019.
English: Do not use in dogs with generalised demodicosis.
Croatian: Ne primjenjivati kod pasa s generaliziranom demodikozom.
English: ATCvet code: QS02CA91
Croatian: ATCvet kod: QS02CA91
English: The maximum clinical response may not be seen until 28 days after administration.
Croatian: Maksimalan klinički odgovor ne mora biti vidljiv do 28 dana nakon primjene.
English: Additional corticosteroid treatments should be avoided.
Croatian: Treba izbjegavati dodatne terapije kortikosteroidima.
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 18 mjeseci
English: It is recommended not to repeat ear cleaning until 28 days after administration of the product.
Croatian: Ne preporučuje se ponavljati čišćenje uha do 28 dana nakon primjene proizvoda.
English: Carton containing 2, 10 or 20 blisters.
Croatian: Kutija sadržava 2, 10 ili 20 blistera.
English: Shake well before use for 5 seconds.
Croatian: Prije primjene dobro promućkati 5 sekundi.
English: May be harmful after ingestion.
Croatian: Može biti štetno nakon gutanja.
English: Mometasone furoate is a corticosteroid with high potency.
Croatian: Mometazon furoat je kortikosteroid s visokom potencijom.
English: If hypersensitivity to any of the components occurs, the ear should be thoroughly washed.
Croatian: Ako se pojavi preosjetljivost na neku od komponenti, uho treba temeljito oprati.
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 moguće, primjena veterinarsko-medicinskog proizvoda trebala bi se temeljiti na identifikaciji uzročnika i testu osjetljivosti.
English: Accidental eye exposure may occur when the dog shakes its head during or just after administration.
Croatian: Do nehotičnog izlaganja oka može doći kada pas trese glavom za vrijeme ili neposredno nakon aplikacije.
English: Pharmacotherapeutic group: Otologicals/Corticosteroids and anti-infectives in combination.
Croatian: Farmakoterapijska grupa: otologici/ kortikosteroidi i antiinfektivi u kombinaciji.
English: In case of accidental ocular exposure, flush the eyes thoroughly with water for 10 to 15 minutes.
Croatian: U slučaju nehotičnog izlaganja, oko treba temeljito ispirati vodom 10-15 minuta.
English: Like other corticosteroids, it has antiinflammatory and anti-pruritic properties.
Croatian: Kao i drugi kortikosteroidi, ima protuupalna i antipruritička svojstva.
English: Appropriate measures (e.g. wearing safety glasses during administration, massaging the ear canal well after administration to ensure even distribution of product, restraining the dog after administration) are needed to avoid exposure to the eyes.
Croatian: Prikladne mjere (npr. nošenje zaštitnih naočala tijekom primjene, masaža slušnog kanala nakon aplikacije kako bi se osigurala ravnomjerna raspodjela proizvoda, obuzdavanje psa nakon primjene) potrebne su kako bi se izbjeglo izlaganje očiju.
English: After 3 weekly administrations of up to 5x the recommended posology, the test product induced slight erythema in one or both ears that returned to normal within 48 hours.
Croatian: Nakon 3 tjedne primjene peterostruke preporučene doze, ispitivani proizvod uzrokovao je blagi eritem u jednom ili oba uha koji se povukao u roku 48 sati.
English: In cases of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Croatian: U slučajevima parazitske upale uha, potrebno je primijeniti prikladnu akaricidnu terapiju.
English: Single treatment.
Croatian: Jednokratna primjena.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Croatian: U nedostatku studija kompatibilnosti ovaj veterinarsko-medicinski proizvod ne smije se miješati s drugim veterinarsko-medicinskim proizvodima.
English: EU/2/19/246/001 (2 tubes) EU/2/19/246/002 (10 tubes) EU/2/19/246/003 (20 tubes)
Croatian: EU/2/19/246/002 (10 tuba) EU/2/19/246/003 (20 tuba)
English: Restrain the dog's head to prevent shaking, for 2 minutes.
Croatian: Obuzdajte psu glavu kako je ne bi tresao 2 minute.
English: The veterinary medicinal product has serious eye irritation potential.
Croatian: Veterinarsko-medicinski proizvod može izazvati ozbiljnu iritaciju oka.
English: Do not use in case of hypersensitivity to the active substances, to other corticosteroids or to any of the excipients.
Croatian: Ne primjenjivati u slučaju preosjetljivosti na djelatne tvari, na druge kortikosteroide ili na bilo koju od pomoćnih tvari.
English: Other potentially treatment-related effects included mild changes to aspartate aminotransferase (AST), total protein, cholesterol, inorganic phosphorus, creatinine and calcium.
Croatian: Drugi potencijalni učinci povezani s terapijom uključuju blage promjene aspartat aminotransferaze (AST), ukupnih proteina, kolesterola, anorganskog fosfora, kreatinina i kalcija.
English: 2 tubes 10 tubes 20 tubes
Croatian: 2 tube 10 tuba 20 tuba
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis, through binding to and acting on the 50S ribosomal subunit of bacteria.
Croatian: Florfenikol je bakteriostatski antibiotik koji djeluje tako da inhibira sintezu proteina vezanjem i djelovanjem na 50S ribosomsku podjedinicu bakterija.
English: Clear, colourless to yellow, slightly viscous liquid.
Croatian: Bistra, bezbojna do žuta, blago viskozna tekućina.
English: 1 dose (1 ml) contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 doza (1 mL) sadržava:
English: Florfenicol: 16.7 mg
Croatian: Florfenikol: 16,7 mg
English: The extent of transcutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Croatian: Stupanj transkutane apsorpcije lokalno primjenjenih proizvoda određuju mnogi čimbenici uključujući integritet epidermalne barijere.
English: Terbinafine hydrochloride is an allylamine with a pronounced fungicidal activity.
Croatian: Terbinafin hidroklorid je alilamin s izraženim fungicidnim djelovanjem.
English: Ears must be cleaned before administration of the product.
Croatian: Uši se moraju očistiti prije primjene proizvoda.
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 2 μg/ml).
Croatian: Njegov spektar djelovanja uključuje grampozitivne i gram-negativne bakterije uključujući Staphylococcus pseudintermedius (MIC90 od 2 μg/ml).
English: The recommended dosage is 1 single-dose container (i.e. 1 ml of solution) per infected ear.
Croatian: Preporučena doza iznosi 1 jednodozni spremnik (1 mL otopine) za jedno inficirano uho.
English: Although no potential for skin irritation was indicated by experimental studies, contact of the product with the skin should be avoided.
Croatian: Iako tijekom pokusnih ispitivanja nije zabilježena mogućnost nadraživanja kože, treba izbjegavati kontakt s kožom.
English: Inflammation can increase the transcutaneous absorption of veterinary medicinal products across the skin adjacent to the external opening of the ear canal.
Croatian: Upala može povećati transkutanu apsorpciju veterinarsko-medicinskih proizvoda preko kože uz vanjski otvor slušnog kanala.
English: Vocalisation, head shaking and application site pain shortly after product application have been reported very rarely in spontaneous (pharmacovigilance) reports.
Croatian: Glasanje, otresanje glavom i bol na mjestu primjene neposredno nakon primjene proizvoda zabilježeni su vrlo rijetko u spontanim izvještajima farmakovigilancije.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the outer carton and container label after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i spremniku poslije EXP.
English: Bacterial and fungal otitis is often secondary to other conditions.
Croatian: Bakterijska i gljivična upala uha često su sekundarne upale.
English: Use with caution in dogs with a suspected or confirmed endocrine disorder (e.g., diabetes mellitus, hypo- or hyperthyroidism, etc.).
Croatian: Koristite oprezno kod pasa sa suspektnim ili potvrđenim endokrinološkim poremećajem (npr. diabetes mellitus, hipo- ili hipertireoidizam i slično).
English: Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated.
Croatian: Prije primjene veterinarsko-medicinskog proizvoda, potrebno je pregledati vanjski slušni kanal kako bi se uvjerili da bubnjić nije perforiran.
English: In clinical trials, only saline was used for ear cleaning before treatment initiation with the veterinary medicinal product.
Croatian: U kliničkim ispitivanjima, za čišćenje uha korištena je samo fiziološka otopina prije početka primjene veterinarsko-medicinskog proizvoda.
English: However, no safety issues were identified in field studies in dogs weighing less than 4kg.
Croatian: Međutim, nisu uočeni problemi s neškodljivosti u terenskim ispitivanjima kod pasa lakših od 4 kg.
English: After the administration, wet ears or clear discharge can be observed which is not related to the disease pathology.
Croatian: Nakon aplikacije, uši mogu biti vlažne ili se može uočiti bistri iscjedak što nije povezano s patologijom bolesti.
English: Decreased cortisol levels were observed after product instillation in tolerance studies (before and after ACTH stimulation), indicating that mometasone furoate is absorbed and enters the systemic circulation.
Croatian: Smanjene razine kortizola uočene su nakon unošenja proizvoda u studije tolerancije (prije i poslije ACTH stimulacije), što ukazuje da se mometazon furoat apsorbira i ulazi u sistemsku cirkulaciju.
English: Studies to determine the effect on fertility in dogs have not been conducted.
Croatian: Nisu provedeni pokusi utjecaja na plodnost kod pasa.
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 primjenjuje samo veterinar ili da se primjenjuje pod strogim nadzorom veterinara.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU VANJSKI KARTON
English: Cfr modifies the RNA in the drug binding site (causing reduced affinity to chloramphenicol, florfenicol and clindamycin) and the cfr gene can be present in plasmids or other transmissible elements.
Croatian: Cfr modificira RNA na mjestu vezanja lijeka (uzrokujući smanjen afinitet na kloramfenikol, florfenikol i klindamicin) i cfr gen može biti prisutan u plazmidima ili drugim prenosivim elementima.
English: Systemic absorption of the three active substances was determined after single co-administration into one ear canal of healthy beagle dogs.
Croatian: Sustavna apsorpcija tri djelatne tvari određena je nakon jednokratne aplikacije u jedan slušni kanal zdravih pasa pasmine Bigl.
English: The safety of the veterinary medicinal product has not been established in dogs less than 3 months of age.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije potvrđena kod pasa mlađih od 3 mjeseca.
English: After application, gently massage the base of the ear for 30 seconds to allow distribution of the solution.
Croatian: Nakon aplikacije nježno masirajte bazu uha 30 sekundi kako biste omogućili da se otopina raspodjeli.
English: Do not use in pregnant or breeding animals.
Croatian: Ne primjenjivati kod gravidnih ili rasplodnih životinja.