FrancophonIA/ELRC3.0 huggingface dataset:
English: If your child has poor lung function your child's doctor may monitor your child more closely when she/he starts Orkambi.
Croatian: Ako Vaše dijete ima slabu plućnu funkciju, kada počne uzimati
English: • Nasal congestion
Croatian: • začepljenost nosa
English: • Food containing fat should be given to your child just before or just after dosing (some examples are provided below).
Croatian: • Neposredno prije ili neposredno poslije doziranja, djetetu treba dati hranu koja sadrži masti
English: LIST OF EXCIPIENTS
Croatian: Lumakaftor i ivakaftor
English: • Stuffy or runny nose
Croatian: • začepljenost nosa ili curenje nosa
English: Potential for lumacaftor/ivacaftor to affect other medicinal products CYP3A substrates
Croatian: Mogući utjecaj lumakaftora/ivakaftora na druge lijekove
English: One lumacaftor 100 mg/ivacaftor 125 mg sachet every 12 hours lumacaftor 200 mg/ ivacaftor 250 mg
Croatian: LUM 400 mg / IVA 250 mg svakih 12 sati Placebo / LUM 400 mg / IVA 250 mg svakih 12 sati Placebo
English: Changes in ppFEV1 in response to lumacaftor alone or in combination with ivacaftor were also evaluated in the double-blind, placebo-controlled, Phase 2 trial in patients with CF age 18 years and older.
Croatian: U dvostruko slijepom, placebom kontroliranom ispitivanju faze 2 u bolesnika s cističnom fibrozom u dobi od 18 i više godina procijenjene su i promjene u vrijednosti ppFEV1 kao odgovor na lumakaftor primijenjen sam ili u kombinaciji s ivakaftorom.
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tableta sadrži 100 mg lumakaftora i 125 mg ivakaftora.
English: Cellulose, microcrystalline Croscarmellose sodium Hypromellose acetate succinate Povidone (K30) Sodium laurilsulfate Magnesium stearate
Croatian: Jezgra tablete celuloza, mikrokristalična karmelozanatrij, umrežena hipromelozaacetatsukcinat povidon (K30)
English: • Yellowing of your skin or the white part of your eyes
Croatian: • koža ili bjeloočnice Vam postaju žute boje
English: Sodium
Croatian: Doza
English: Day 1: lumacaftor 200 mg + ivacaftor 250 mg Day 2: lumacaftor 100 mg + ivacaftor 125 mg
Croatian: Za bolesnike u dobi od 2 do 5 godina i < 14 kg 1. dan: 200 mg lumakaftora + 250 mg ivakaftora 2. dan: 100 mg lumakaftora + 125 mg ivakaftora
English: Lumacaftor
Croatian: lumakaftorom
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tableta sadrži 200 mg lumakaftora i 125 mg ivakaftora.
English: What you need to know before your child takes Orkambi Do not take Orkambi
Croatian: Vaše dijete ne smije uzimati Orkambi
English: Frequency
Croatian: telitromicinom
English: Coating
Croatian: Doziranje
English: EU (MA) number Invented name
Croatian: Izmišljeno ime
English: 1 pre-filled syringe Not applicable
Croatian: 1 unaprijed napunjena štrcaljka
English: Content Package size Withdrawal period
Croatian: Sastav Veličina pakovanja
English: Immediate packaging
Croatian: Put primjene Unutarnjim pakovanje
English: No other concern was notified by the reference Member State.
Croatian: Referentna država članica nije navela ni jednu drugu zabrinutost.
English: − PSURs shall be provided every 6 months for the first 5 years of commercialisation.
Croatian: − PSUR-ovi se moraju dostavljati svakih 6 mjeseci tijekom prvih pet godina komercijalizacije.
English: For the mutual recognition procedure (MRP), Belgium acted as a reference Member State and Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom were concerned Member States.
Croatian: Za postupak međusobnog priznavanja (MRP) Belgija je imala ulogu referentne države članice, a Bugarska, Hrvatska, Francuska, Njemačka, Irska, Italija, Nizozemska, Poljska, Portugal, Rumunjska, Slovenija, Španjolska i Ujedinjena Kraljevina bile su države članice sudionice u postupku.
English: However, a concern remains and the MAH committed to further investigate this result in two additional similar studies.
Croatian: Međutim, i dalje je prisutna zabrinutost te se nositelj odobrenja za stavljanje u promet obvezao na daljnju istragu tog rezultata u dvama dodatnim sličnim ispitivanjima.
English: Vaccines are important tools to combat Bovine Herpesvirus Type 1 Infection which is a notifiable disease in several Member States, e.g. Austria, Denmark, Germany.
Croatian: Cjepiva su važno sredstvo u borbi protiv infekcije goveđim herpes virusom tipa 1 koja je prijavljena bolest u nekoliko država članica, npr. u Austriji, Danskoj, Njemačkoj.
English: Exclusion of infectious, toxic or any other cause in live animals, to be further detailed in the risk management plan.
Croatian: 1. isključivanje zaraznog, toksičnog ili bilo kojeg drugog uzroka u živih životinja, koje će biti detaljno opisano u planu upravljanja rizikom.
English: Data have been provided to demonstrate the efficiency of the filtration step.
Croatian: Pruženi su podaci koji dokazuju djelotvornost filtracije.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant/marketing authorisation holder in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačine veterinarskog lijeka, životinjske vrste, načina davanja, nositelja odobrenja za stavljanje lijeka u promet u Državama članicama
English: The epidemiology of the disease is difficult to describe as a number of potential biases may have influenced the results.
Croatian: Epidemiologiju bolesti teško je opisati jer bi niz mogućih pristranosti mogao utjecati na rezultate.
English: Additionally, a surveillance and monitoring strategy has been proposed, which together with the suggested studies is deemed adequate and proportionate to the identified risk.
Croatian: Osim toga, predložena je strategija nadzora i praćenja koja se zajedno s predloženim ispitivanjima smatra prikladnom i razmjernom utvrđenom riziku.
English: Risk management measures
Croatian: Mjere za upravljanje rizikom
English: With Commission Decisions 5694 of 10/08/2010 and 7077 of 07/10/2010 the marketing authorisations for PregSure BVD were suspended.
Croatian: Na temelju odluka Komisije 5694 od 10. kolovoza 2010. i 7077 od 7. listopada 2010. obustavljena su odobrenja za stavljanje u promet VMP-a PregSure BVD.
English: To address the concerns on alloantibody response the marketing authorisation holder should ensure that the results of the study can be reliably interpreted.
Croatian: Kako bi se riješile zabrinutosti u pogledu reakcije na aloprotutijela, nositelj odobrenja za stavljanje u promet trebao bi osigurati da se rezultati ispitivanja mogu pouzdano tumačiti.
English: Should proposals for alternative immunisation schemes, indications, or contraindications be necessary, these regulatory measures should also be handled consistently with the normal operating practices for adverse event reports and variations associated with veterinary medicinal products.
Croatian: U slučaju da prijedlozi alternativnih planova imunizacije, indikacije ili kontraindikacije budu potrebni, s tim je regulatornim mjerama također potrebno dosljedno postupati s uobičajenim radnim praksama u slučajevima izvješća o štetnim događajima i varijacijama povezanima s veterinarsko-medicinskim proizvodima.
English: These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Croatian: Ta su pitanja ostala neriješena i stoga je pokrenut postupak upućivanja u skladu s člankom 33. stavkom 1. Direktive 2001/82/EZ Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za veterinarskomedicinske proizvode (CMDv).
English: − Show that there is no impact of the scaling-up (considering a worst-case scenario, i.e. the maximum commercial batch) on the efficiency of consistently decreasing the total protein content.
Croatian: Mora dokazati da nema učinka povećanja (uzimajući u obzir najgori mogući ishod, tj. maksimalnu seriju na tržištu) na djelotvornost dosljednog smanjenja ukupnog sadržaja proteina.
English: • The marketing authorisation holder shall implement a single risk management plan addressing the following risk mitigation and surveillance measures:
Croatian: • Nositelj odobrenja za stavljanje u promet mora provesti jedinstveni plan upravljanja rizikom u kojem će se riješiti sljedeće mjere smanjenja rizika i praćenja:
English: Several live and inactivated IBR marker vaccines are authorised and successfully used throughout the EU.
Croatian: Nekoliko živih i inaktiviranih marker-cjepiva protiv ZRG-a odobreno je i uspješno se primjenjuje diljem EU-a.
English: The marketing authorisation holder (MAH), Zoetis Belgium SA, submitted an application for mutual recognition of the marketing authorisation granted by Belgium in accordance with Article 32 of Directive 2001/82/EC.
Croatian: Nositelj odobrenja za stavljanje u promet, Zoetis Belgium SA, dostavio je prijavu za međusobno priznavanje odobrenja za stavljanje u promet koje je izdala Belgija u skladu s člankom 32. Direktive 2001/82/EZ.
English: Updates to the risk management plan should be proposed as required as soon as any issues arise, otherwise the risk management plan should be reviewed on a yearly basis at least, in conjunction with the PSUR submission.
Croatian: Po potrebi je potrebno predložiti ažuriranja plana upravljanja rizikom čim se pojavi bilo kakav problem, a u suprotnom je potrebno pregledati plan upravljanja rizikom barem jednom godišnje, zajedno s dostavljanjem PSUR-a.
English: The risk management plan should be submitted to the national competent authorities within 6 months of the Commission Decision and maintained until such time as the concerned national competent authorities consider that the risk profile of the product has been sufficiently characterised and all appropriate risk mitigation and surveillance measures have been implemented.
Croatian: Plan upravljanja rizikom potrebno je dostaviti nadležnim nacionalnim tijelima u roku od 6 mjeseci nakon odluke Komisije te ga provoditi sve dok predmetna nadležna nacionalna tijela ne budu smatrala da je profil rizika proizvoda u dostatnoj mjeri opisan i da su primijenjene sve odgovarajuće mjere za ublažavanje rizika i nadzor.
English: This thorough investigations includes: 1.
Croatian: Navedena detaljna istraga obuhvaća:
English: The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Croatian: Nacionalna nadležna tijela, koja koordinira referentna država članica, osigurava da nositelj odobrenja za stavljanje promet ispunjava sljedeće uvjete:
English: As lack of alloantibody response would be anticipated leading to negative results they should be compared with the available data on Pregsure BVD and with an appropriate internal positive control.
Croatian: Budući da bi izostanak reakcije na aloprotutijela bio očekivan i doveo do negativnih rezultata, potrebno ih je usporediti s dostupnim podacima o VMP-u PregSure BVD te s odgovarajućom unutarnjom pozitivnom kontrolom.
English: The limit should be equal to or below the quantity of total protein of the CattleMarker IBR vaccine used in hyperimmunisation study 9134R-08-11-457.
Croatian: Granica bi trebala biti jednaka ili ispod ukupne količine proteina u CattleMarker inaktiviranom cjepivu protiv ZRG-a koja je upotrijebljena u hiperimunizacijskom ispitivanju 9134R-08-11-457.
English: There have been great variations in pharmacovigilance reporting and it is difficult to conclude whether they are related to genuine variations of frequency of BNP occurrence or because of the differences of the information gathered on the condition.
Croatian: Bile su prisutne znatne varijacije u farmakovigilancijskom izvješćivanju te je teško zaključiti jesu li one povezane sa stvarnim varijacijama u učestalosti pojave BNP-a ili je do njih došlo zbog razlika u informacijama prikupljenima o toj bolesti.
English: − Clinically validate the upper limit for total protein content.
Croatian: Mora klinički potvrditi gornju granicu ukupnog sadržaja proteina.
English: Due to the efficiency and safety of the gE deleted IBR vaccines currently on the market the eradication of IBR is making good progress and several European countries are on the way towards freedom from BoHV-1.
Croatian: Zbog djelotvornosti i sigurnosti cjepiva protiv ZRG-a s uklonjenim gE-om koja su trenutačno na tržištu, postignut je napredak u iskorjenjivanju ZRG-a, a nekoliko europskih zemalja na dobrom je putu da se oslobode virusa GHV-1.
English: • The marketing authorisation holder shall include a new specification in the finished product of a maximum total protein content.
Croatian: • Nositelj odobrenja za stavljanje u promet uključit će u konačni proizvod novu specifikaciju u maksimalnog ukupnog sadržaja proteina.
English: Since the issues raised by Germany remained unresolved, the Member States concerned failed to reach agreement regarding the marketing authorisation CattleMarker IBR Inactivated and consequently the matter was referred to the CVMP on 29 September 2015 under Article 33(4) of Directive 2001/82/EC.
Croatian: Budući da su pitanja koja je postavila Njemačka ostala neriješena, države članice sudionice u postupku nisu mogle postići sporazum u vezi s odobrenjem za stavljanje u promet VMP-a CattleMarker inaktivirano cjepivo protiv ZRG-a, zbog čega je predmet upućen CVMP-u 29. rujna 2015. u skladu s člankom 33. stavkom 4. Direktive 2001/82/EZ.
English: BNP is a disease which can be fatal in neonatal calves and which has been experimentally reproduced by the intake of colostrum from dams which have alloantibodies.
Croatian: BNP je bolest koja u neonatalne teladi može biti smrtonosna te koja je eksperimentalno reproducirana unosom kolostruma iz ženki koje imaju aloprotutijela.
English: • to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
Croatian: • radi smanjenja pojave pobačaja povezanih s infekcijama virusom GHV-1 kao što je dokazano tijekom drugog tromjesečja gestacije nakon infekcije.
English: Onset of protection for female cattle is 2 weeks or 19 days prior to breeding or insemination and duration is 12 months post primary vaccination.
Croatian: Zaštita ženki počinje 2 tjedna ili 19 dana prije oplodnje ili inseminacije, a traje 12 mjeseci nakon primarnog cijepljenja.
English: Scientific conclusions and grounds for the granting of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za odobrenje za stavljanje u promet
English: To set this specification the marketing authorisation holder shall:
Croatian: Kako bi odredio tu specifikaciju, nositelj odobrenja za stavljanje u promet mora provesti stavke u nastavku:
English: Later the marketing authorisations for PregSure BVD were withdrawn by the MAH Pfizer (now Zoetis) from all EU and in 2011 even from non-EU countries after reports about BNP cases in PregSure BVD-vaccinated herds in New Zealand became public.
Croatian: Naknadno je nositelj odobrenja Pfizer (današnji Zoetis) s područja cijelog EU-a povukao odobrenja za stavljanje u promet VMP-a PregSure BVD, a 2011. čak i u zemljama koje nisu članice EU-a nakon što su objavljena izvješća o slučajevima BNP-a u stadima cijepljenjima VMP-om PregSure BVD na Novom Zelandu.
English: Animal species Route of administration
Croatian: Farmaceutski oblik Ciljne vrste životinja
English: Any confirmed BNP calves will also be assessed for MHC-I alloantibodies.
Croatian: Sva telad s potvrđenim BNPom također će biti ispitana radi utvrđivanja aloprotutijela MHC-I.
English: A filtration step using three filtration membranes has been integrated into the production process for clarification of the antigen preparations.
Croatian: U postupak proizvodnje uključena je filtracija s pomoću triju filtracijskih opni radi pročišćavanja priprema antigena.
English: In the past initially epidemiological information and then rapidly increasing pharmacovigilance data documented an increase of the frequency of this alloimmune reaction between the dam and the foetus and finally a close relationship between the occurrences of BNP and the repeated vaccination of dams with PregSure BVD was established.
Croatian: U prošlosti je u početku epidemiološkim informacijama, a zatim i naglo rastućim farmakovigilancijskim podacima zabilježeno povećanje učestalosti ove aloimunološke reakcije između ženke i fetusa, a naposljetku je utvrđena bliska povezanost između pojava BNP-a i ponovljenih cijepljenja ženki VMP-om PregSure BVD.
English: Active immunisation of female cattle from 6 months of age is also indicated:
Croatian: Veterinarsko-medicinski proizvod (VMP) također je indiciran za aktivnu imunizaciju ženki goveda od 6 mjeseci starosti:
English: − The marketing authorisation holder should consider the development a method for assaying the protein content in the finished product.
Croatian: Nositelj odobrenja za stavljanje u promet trebao bi razmotriti razvoj načina testiranja sadržaja proteina u gotovom proizvodu.
English: These results show that the overall protein content per ml is higher in BVDV-1 antigen batches than in BoHV1 antigen batches.
Croatian: Ti rezultati dokazuju da je ukupni sadržaj proteina po mililitru veći u serijama antigena BVDV-1 nego li u serijama antigena GHV-1.
English: The frequency of this condition had been dramatically exacerbated by PregSure BVD vaccination in the 2000's leading to the characterisation of a strong association between the occurrence of BNP and the use of Pregsure BVD; however the frequency of BNP disease caused by PregSure BVD vaccination has not been solidly determined, varying from 5% to 0.004% according to the source; the CVMP approximated this frequency to be around 0.01% during the Article 78 procedure.
Croatian: Učestalost te bolesti dramatično je pogoršana cijepljenjem VMP-om PregSure BVD tijekom 2000-ih što je dovelo do stvaranja snažne povezanosti između pojave BNP-a i primjene VMP-a PregSure BVD; međutim, učestalost zaraze BNP-om prouzročene cijepljenjem VMP-om PregSure BVD nije čvrsto ustanovljena, varirajući od 5 % do 0,004 % ovisno o izvoru; CVMP je tijekom postupka u skladu s člankom 78. utvrdio da je učestalost približno 0,01 %.
English: The abovementioned study results should be provided to the relevant national competent authorities for assessment prior to placing CattleMarker IBR Inactivated on the EU market and within 24 months of the Commission Decision.
Croatian: Prethodno navedene rezultate ispitivanja trebalo bi dostaviti predmetnim nadležnim nacionalnim tijelima na procjenu prije stavljanja VMP-a CattleMarker inaktivirano cjepivo protiv ZRG-a na tržište EU-a te u roku od 24 mjeseca nakon odluke Komisije.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Croatian: Valjani sažetak opisa svojstava , valjano označivanje VMP-a i valjana uputa o VMP-u predstavljaju konačne verzije usuglašene tijekom postupka Koordinacijske grupe.
English: The proposed measures, which will be included in a risk management plan, are considered proportionate and the most efficient way to tackle the BNP risk.
Croatian: Predložene mjere, koje će biti uključenje u plan upravljanja rizikom, smatraju se razmjernima te najdjelotvornijim načinom rješavanja rizika od BNP-a.
English: A large scale post-marketing prospective survey is deemed less effective to identify whether the level of BNP is acceptable when compared with the surveillance and monitoring strategy proposed, because the number of animals to be enrolled in such a study would exceed several thousands of animals (due to the estimated BNP frequency of around 0.01%) and the time span anticipated for BNP cases to occur consecutive to vaccination would not be shorter.
Croatian: Opsežno prognostičko ispitivanje nakon dobivanja odobrenja za stavljanje VMP-a u promet smatra se manje učinkovitim za utvrđivanje je li razina BNP-a prihvatljiva u usporedbi s predloženom strategijom nadzora i praćenja jer bi broj životinja koje je potrebno obuhvatiti ispitivanjem premašio nekoliko tisuća (zbog procijenjene učestalosti BNP-a na približno 0,01 %), a predviđeno razdoblje za pojavu slučajeva BNP-a nakon cijepljenja ne bi bilo kraće.
English: If alive, profound thrombocytopenia (with or without neutropenia, lymphopenia and nonregenerative anaemia).
Croatian: 3. u živih životinja potpunu trombocitopeniju (s ili bez neutropenije, limfopenije i neregenerativne anemije).
English: If dead, bone marrow histopathology shows trilineage hypoplasia.
Croatian: 2. u uginulih životinja histopatologija koštane srži ukazuje na trilinijsku hipoplaziju.
English: In 2010, due to these concerns, a procedure under Article 78 of Directive 2001/82/EC was initiated in which the CVMP concluded that although the aetiology of BNP had yet to be determined there was evidence to suggest that PregSure BVD may be associated with BNP and that the benefit-risk balance for the product was unfavourable.
Croatian: Zbog tih je zabrinutosti 2010. pokrenut postupak u skladu s člankom 78. Direktive 2001/82/EZ u kojem je CVMP donio zaključak da, iako je još bilo potrebno odrediti etiologiju BVD-a, postoje dokazi koji ukazuju na to da bi VMP PregSure BVD mogao biti povezan s BNP-om te da je omjer koristi i rizika u pogledu tog VMP-a nepovoljan.
English: An association between BNP and alloimune reaction to Antigens Not related to the Active Substance (ANAS) (e.g. bovine kidney cell line derived antigens and all antigenic substances remaining from the manufacturing process) is widely accepted.
Croatian: Prihvaćena je povezanost između BNP-a i aloimunološke reakcije na antigene koji nisu povezani s djelatnom tvari (ANAS) (npr. antigeni dobiveni iz stanične linije bubrega goveda i sve preostale antigenske tvari iz proizvodnog postupka).
English: Annex IV Conditions of the marketing authorisations
Croatian: Prilog IV. Uvjeti odobrenja za stavljanje u promet
English: Nonetheless in the assessment in the frame of this procedure under Article 78 of Directive 2001/82/EC the frequency of the BNP caused by PregSure BVD was approximated to be around 0.01% by the CVMP.
Croatian: Međutim, u ocjenjivanju u okviru ovoga postupa u skladu s člankom 78. Direktive 2001/82/EZ CVMP je utvrdio da je učestalost BNP-a prouzročenog VMP-om PregSure BVD otprilike 0,01 %.
English: Onset and duration of protection for the seronegative cattle form 2 weeks of age is 2 weeks and 6 months respectively after completion of the primary vaccination
Croatian: Zaštita seronegativnih goveda od 2 tjedna starosti počinje 2 tjedna te traje 6 mjeseci nakon primarnog cijepljenja.
English: The product is indicated for active immunisation of seronegative cattle from 2 weeks of age to reduce the clinical signs (pyrexia and depression) of IBR and the duration of virus shedding caused by BoHV-1 infection.
Croatian: Proizvod je indiciran za aktivnu imunizaciju seronegativnih goveda od 2 tjedna starosti radi smanjenja kliničkih znakova (pireksija i depresija) ZRG-a te trajanja faze izlučivanja virusa kao posljedice infekcije virusom GHV-1.
English: During the MRP Germany raised a concern about the immunological safety of CattleMarker IBR Inactivated, as the composition of this product is similar to PregSure BVD, a vaccine which has been shown to induce a long-lasting allogeneic antibody response which has been associated with Bovine Neonatal Pancytopenia (BNP), a neonatal alloimmune disease, in the progeny of vaccinated dams.
Croatian: Tijekom MRP-a Njemačka je izrazila zabrinutost u pogledu imunološke sigurnosti VMP-a CattleMarker inaktivirano cjepivo protiv ZRG-a jer je njegov sastav sličan VMP-u PregSure BVD, cjepivu koje dokazano izaziva dugotrajnu alogeničnu reakciju protutijela koja je povezana s goveđom neonatalnom pancitopenijom (BNP), neonatalnom aloimunološkom bolešću, u potomstvu cijepljenih ženki.