FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 150 IU/0.25 mL injection follitropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bemfola 150 IU/0,25 ml injekcija folitropin alfa s.c.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA B[MI3]emfola 300 IU/0,50 ml otopina za injekciju u napunjenoj brizgalici
English: Each cartridge contains 0.25 mL solution for injection.
Croatian: Svaki uložak sadrži 0,25 ml otopine za injekcije.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,25 ml
English: 5 or 10 alcohol swabs.
Croatian: 5 jastučića od vate natopljenih alkoholom
English: NAME OF THE MEDICINAL PRODUCT Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA B[MI1]emfola 150 IU/0,25 ml otopina za injekciju u napunjenoj brizgalici
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.75 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,75 ml
English: NAME OF THE MEDICINAL PRODUCT Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen follitropin alfa
Croatian: Bemfola 225 IU/0,375 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa
English: Clean the injection site with the alcohol swab using a circular motion.
Croatian: Kružnim pokretima očistite odabrano područje kože jastučićem od vate natopljenog alkoholom.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 300 IU/0.5 mL solution for injection in pre-filled pen follitropin alfa
Croatian: Bemfola 300 IU/0,5 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa
English: NAME OF THE MEDICINAL PRODUCT Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA B[MI4]emfola 450 IU/0,75 ml otopina za injekciju u napunjenoj brizgalici
English: (hMG).
Croatian: FSH-om.
English: Each cartridge contains 0.5 mL solution for injection.
Croatian: Svaki uložak sadrži 0,50 ml otopine za injekcije.
English: Each cartridge contains 0.75 mL solution for injection.
Croatian: Svaki uložak sadrži 0,75 ml otopine za injekcije.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen follitropin alfa
Croatian: Bemfola 75 IU/0,125 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa
English: • If you are a woman: with large ovaries or sacs of fluids within the ovaries (ovarian cysts) of unknown origin.
Croatian: - i imate povećane jajnike ili vrećice s tekućinom u jajnicima (ciste na jajnicima)
English: Each pre-filled pen delivers 75 IU follitropin alfa, equivalent to 5.5 micrograms per 0.125 mL.
Croatian: Jedna napunjena brizgalica osigurava primjenu 75 IU folitropina alfa, što odgovara 5,5 mikrograma u 0,125 ml. Jedan ml otopine sadrži 600 IU, što odgovara 44 mikrograma.
English: Complication of severe OHSS General disorders and administration site conditions Very common: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Croatian: reakcije na mjestu injiciranja (bol, eritem, hematom, oticanje i/ili iritacija na mjestu injiciranja)
English: NAME OF THE MEDICINAL PRODUCT Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen follitropin alfa
Croatian: Bemfola 150 IU/0,25 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa
English: The patient is recommended to have coitus on the day of, and the day following hCG administration.
Croatian: Pacijentici se preporučuje spolni odnos na dan injekcije hCG-a i dan poslije.
English: NAME OF THE MEDICINAL PRODUCT Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen follitropin alfa
Croatian: Bemfola 450 IU/0,75 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa
English: Total dose of FSH required (number of FSH 75 IU ampoules) 27.6 ± 10.2 40.7 ± 13.6 Need to increase the dose (%)
Croatian: Broj dobivenih oocita Broj dana potrebnih za stimulaciju primjenom FSH-a Ukupan broj potrebnih doza FSH-a (broj ampula FSH-a od 75 IU )
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/909/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/909/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/909/004
English: For instructions on the administration with the pre-filled pen, see the package leaflet.
Croatian: Upute o primjeni napunjene brizgalice potražite u uputi o lijeku.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/909/001
English: Remove the outer needle cap. Keep it for later.
Croatian: Sačuvajte ga za poslije.
English: Women with anovulation (including polycystic ovarian syndrome) Follitropin alfa may be given as a course of daily injections.
Croatian: • Anovulacija (uključujući sindrom policističnih jajnika [engl. polycystic ovarian syndrome,
English: Thromboembolism (both in association with and separate from OHSS) Respiratory, thoracic and mediastinal disorders Very rare:
Croatian: blage do teške reakcije preosjetljivosti, uključujući anafilaktičke reakcije i šok Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo rijetko:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/909/003
English: Number of oocytes retrieved
Croatian: komplikacije teškog OHSS-a
English: Conclusions presented by the European Medicines Agency on:
Croatian: Zaključci Europske agencije za lijekove:
English: The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
Croatian: Nakon razmatranja zahtjeva, mišljenje je CHMP-a da je omjer rizika i koristi povoljan te se može preporučiti davanje uvjetnog odobrenja za stavljanje lijeka u promet, što je dodatno pojašnjeno u
English: • Conditional marketing authorisation
Croatian: • Uvjetno odobrenje za stavljanje lijeka u promet
English: ANNEX IV Conclusions on the granting of the conditional marketing authorisation presented by the European Medicines Agency
Croatian: PRILOG IV. Zaključci Europske agencije za lijekove o davanju uvjetnog odobrenja za stavljenje lijeka u promet
English: MA (EU) Number
Croatian: Broj (EU) odobrenja
English: Powder for concentrate for solution for infusion
Croatian: 1 mg Prašak za koncentrat za otopinu za infuziju
English: Strength Pharmaceutical Form
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik
English: Intravenous use vial (glass)
Croatian: Bočica (staklena)
English: Administration Immediate Packaging
Croatian: Put primjene Unutarnje pakovanje
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Croatian: EMA (EU) broj
English: Route of administration
Croatian: Farmaceutski oblik
English: Strength Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik
English: The Committee considered that the second approach was the most appropriate in this case.
Croatian: Odbor je mišljenja da je drugi pristup najprimjereniji u ovom slučaju.
English: The application was submitted to the United Kingdom as reference Member State and to Austria, Czech Republic, Estonia, Finland, France, Germany, Greece, Italy, Latvia, the Netherlands, Slovakia and Spain as concerned Member States.
Croatian: Zahtjev je podnijet u Ujedinjenom Kraljevstvu kao referentnoj državi članici, te u Austriji, Češkoj Republici, Estoniji, Finskoj, Francuskoj, Njemačkoj, Grčkoj, Italiji, Latviji, Nizozemskoj, Slovačkoj i Španjolskoj kao dotičnim državama članicama.
English: INN Pharmaceutical form
Croatian: INN Farmaceutskog oblika
English: The worksharing procedure started on 6 January 2012.
Croatian: Postupak podjele rada započeo je dana 6. siječnja 2012. godine.
English: Strength Animal species
Croatian: Jačine Životinjskih vrsta
English: CVMP conclusions after the re-examination
Croatian: Zaključci CVMP-a nakon ponovnog ispitivanja
English: The detailed grounds for re-examination were submitted on 26 April 2013.
Croatian: Detaljno obrazloženja za ponovno ispitivanje dostavljeno je dana 26. travnja 2013. godine.
English: Therefore, it is concluded that data from all available studies should be considered relevant, and as such, must be taken into account.
Croatian: Stoga je zaključeno da se podaci svih dostupnih ispitivanja moraju smatrati relevantnima te kao takvi moraju biti uzeti u obzir.
English: Czech Republic Eurovet Animal Health BV Handelsweg 25
Croatian: Španjolska Eurovet Animal Health BV Handelsweg 25
English: Assessment of the data submitted
Croatian: Ocjena dostavljenih podataka
English: The main shortcoming of the study was the use of a microbiological assay.
Croatian: Glavni nedostatak ispitivanja bila je uporaba mikrobiološke analize.
English: Re-examination procedure
Croatian: Postupak ponovnog ispitivanja
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Croatian: Navođenje naziva, farmaceutskog oblika, jačine veterinarskomedicinskog proizvoda, životinjskih vrsta, načina primjene, nositelja odobrenja za stavljanje u promet u državama članicama
English: This revised withdrawal period of 9 days is considered appropriate to ensure the safety of the consumer.
Croatian: Ovo revidirano razdoblje karencije od 9 dana smatra se odgovarajućim kako bi se osigurala sigurnost potrošača.
English: Moreover, these older studies are superseded if data derived using more up to date and more accurate analytical methods based on chromatography and mass spectroscopy are available.
Croatian: Nadalje, ove starije metode postaju bespredmetne, ako su dostupni podaci prikupljeni aktualnijim i preciznijim metodama temeljenim na kromatografiji i spektroskopiji mase.
English: When microbiological methods of analysis are used, the data they generate can be used in support of a proposal, depending on how well the method had been validated.
Croatian: Prilikom korištenja mikrobioloških metoda analize, podaci koje ove metode generiraju mogu se koristiti za potkrjepljivanje prijedloga ovisno o tome koliko je dobro metoda validirana.
English: The correct number of animals was used and all of the other study details were in accordance with current requirements.
Croatian: Korišten je ispravan broj životinja i svi ostali detalji ispitivanja bili su u skladu s aktualnim zahtjevima.
English: In particular, there is no reason to disregard this study considering that, within the European Union, chickens used for food production may differ considerably by breed, size and age.
Croatian: Posebice, ne postoji razlog da se ne uvaži ovo ispitivanje s obzirom da se, unutar Europske unije, pilići korišteni za proizvodnju hrane mogu uvelike razlikovati prema pasmini, veličini i dobi.
English: A well conducted residue depletion study using the actual product at the maximum dose for the maximum duration of treatment is considered the most appropriate way to generate data to determine a suitable withdrawal period for a product.
Croatian: Dobro provedeno ispitivanje deplecije rezidua uporabom stvarnog proizvoda pri maksimalnoj dozi za maksimalno trajanje liječenja smatra se najprimjerenijim načinom za generiranje podataka za utvrđivanje prikladne karencije za proizvod.
English: The combined muscle data using the actual values including those below the limit of quantification, a statistically derived meat withdrawal period of 9 days is obtained (F-test: <0.025; Cochran: >0.05; Bartlett: >0.05; Shapiro: >0.10).
Croatian: Objedinjavanjem podataka za mišiće uz primjenu stvarnih vrijednosti, uključujući i one ispod ograničenja kvantifikacije, dobivena je statistički izračunata karencija za meso u trajanju od 9 dana (Ftest: <0.025; Cochran: >0.05; Bartlett: >0.05; Shapiro: >0.10).
English: In this particular case, two residue studies from 1999 and 2011 using the actual formulation at the recommended dose were available.
Croatian: U ovom predmetnom slučaju, dostupna su dva ispitivanja rezidua iz 1999. godine i 2011. godine, u kojima je korištena stvarna formulacija u preporučenoj dozi.
English: The CVMP agreed that there is likely to be no significant difference in the solubility of the products on the market regardless of whether they contain tartaric acid or citric acid.
Croatian: CVMP se složio da vjerojatno nema značajnih razlika u topljivosti proizvoda dostupnih na tržištu bez obzira sadrže li tartarnu ili limunsku kiselinu.
English: The MAH has claimed that the findings from the 2011 study were in line with all other studies with similar and bioequivalent products conducted in Europe in recent years.
Croatian: Nositelj odobrenja za stavljanje u promet tvrdio je da su rezultati ispitivanja provedenog 2011. godine u skladu sa svim ostalim ispitivanjima sličnih i biološki ekvivalentnih proizvoda provedenim u Europi posljednjih godina.
English: This withdrawal period takes into account all the available data and is determined using the statistical approach.
Croatian: Ova karencija uzima u obzir sve dostupne podatke i određena je uz primjenu statističkog pristupa.
English: It was not possible to calculate the meat withdrawal period using the alternative approach as one sample contained residue levels at the MRL level at the last time point (8 days).
Croatian: Nije bilo moguće izračunati karenciju za meso uz primjenu alternativnog pristupa s obzirom da je jedan uzorak sadržavao razine rezidua u razini MRL-a u posljednjoj vremenskoj točki (8 dana).
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje u promet
English: This approach would then result in an overall withdrawal period of 12 days.
Croatian: Ovaj bi pristup rezultirao konačnom karencijom od 12 dana.
English: Residue depletion studies
Croatian: Ispitivanja deplecije rezidua
English: Two options for deriving an overall withdrawal period were therefore considered:
Croatian: Stoga su uzete u razmatranje dvije opcije za izvođenje konačne karencije:
English: One possibility which could partially explain this difference was argued to be the fact that in the 1999 study, the litter was not removed, leading to a recirculation of doxycycline through the natural pecking behaviour of the chickens.
Croatian: Navedena je jedna od mogućnosti koja bi djelomično mogla objasniti ovu razliku, a to je činjenica da u ispitivanju provedenom 1999. godine nije uklonjena stelja, što je uzrokovalo ponovnu cirkulaciju doksiciklina kroz prirodno ponašanje pilića, odnosno kljucanje.
English: The CVMP assessed the detailed grounds for re-examination presented by Eurovet Animal Health BV related to formulation effects and bioequivalence claims, and also to the available residue depletion studies.
Croatian: CVMP je ocijenio detaljne razloge za ponovno ispitivanje koje je dostavilo društvo Eurovet Animal Health BV u vezi s tvrdnjama vezanima za djelovanja formulacije i biološku ekvivalentnost, te u vezi s dostupnim ispitivanjima deplecije rezidua.
English: Option (1) - evaluate each study independently and choose the longer withdrawal period as the overall withdrawal period for the product, as this would represent the worst-case scenario.
Croatian: Opcija (1.) - evaluacija svakog ispitivanja pojedinačno i odabir dulje karencije kao konačnog razdoblja karencije za proizvod budući da ovo razdoblje predstavlja najgori mogući scenarij.
English: This issue remained unsolved and therefore a CMD(v) procedure under Article 13(2) of Commission Regulation (EC) No 1234/2008 has started on 20 August 2012.
Croatian: Ovo je pitanje ostalo neriješeno, te je stoga dana 20. kolovoza 2012. godine CMD(v) započeo postupak sukladno članku 13. (2.) Uredbe Komisije (EZ) br. 1234/2008.
English: Since in the 2011 study, the statistical method could not be used, a withdrawal period of 6 days could be calculated, using the alternative approach.
Croatian: S obzirom da u ispitivanju provedenom 2011. godine nije mogla biti primijenjena statistička metoda, karencija od 6 dana može se izračunati uz primjenu alternativnog pristupa.
English: Because of the presence of tartaric acid in this formulation, the results from the two residue studies are considered valid for assessment, pivotal and necessary in establishing a withdrawal period.
Croatian: S obzirom na prisutnost tartarne kiseline u ovoj formulaciji, rezultati ova dva ispitivanja rezidua smatraju se valjanima za ocjenjivanje, temeljnim i neophodnima za određivanje karencije.
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 30 October 2012, the United Kingdom initiated a referral procedure under Article 13(2) of Commission Regulation (EC) No 1234/2008.
Croatian: S obzirom da referentna država članica i dotične države članice nisu uspjele postići dogovor vezan uz izmjenu, dana 30. listopada 2012. godine Ujedinjeno Kraljevstvo pokrenulo je postupak upućivanja sukladno članku 13. (2.)
English: Option (2) - combine the data from the two studies as, provided that the studies are of acceptable quality, two experiments could result in a better estimate of the ‘true' withdrawal period.
Croatian: Opcija (2.) - objedinjavanje podataka oba ispitivanja budući da dva eksperimenta mogu rezultirati boljom procjenom „prave“ karencije, pod uvjetom da su ispitivanja prihvatljive kvalitete.
English: However, the apparent similarity of solubility within drinking water should not be understood as providing an argument for ruling out definitively a formulation effect due to the presence of tartaric acid.
Croatian: No, očita sličnost u topljivosti u vodi za piće ne može se smatrati argumentom za konačno isključenje učinka formulacije zbog prisutnosti tartarne kiseline.
English: The CVMP has considered whether the differences in the conduct between the two latter residue depletion studies could be used to explain the disparity seen in the resulting withdrawal periods.
Croatian: CVMP je razmatrao mogu li razlike u provođenju ispitivanja između posljednja dva ispitivanja deplecije rezidua poslužiti kao pojašnjenje dispariteta uočenog u rezultirajućim karencijama.
English: The data from the 1999 study could be analysed using the statistical approach, leading to a withdrawal period of 12 days.
Croatian: Podaci ispitivanja provedenog 1999. godine mogu biti analizirani pomoću statističkog pristupa, na temelju kojeg je dobivena karencija od 12 dana.
English: Doxycycline residue levels in muscle were below the muscle MRL from 5 days onwards.
Croatian: Razine rezidua doksiciklina u mišićima bile su niže od maksimalne razine rezidua (MRL) u mišićima od petog dana nadalje.
English: The only significant differences between the conduct of the two studies was with the age and weight of the birds used.
Croatian: Jedine značajne razlike u provođenju dva ispitivanja bile su starost i masa korištenih ptica.
English: It is indicated in chickens to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale.
Croatian: Prašak Soludox namijenjen je za uporabu kod pilića sa ciljem smanjivanja smrtnosti, morbiditeta i kliničkih znakova te smanjivanje lezija izazvanih pasterelozom uzrokovanom bakterijom pasteurella multocida ili sa ciljem smanjivanja morbiditeta i lezija kod respiratornih infekcija uzrokovanih bakterijom ornithobacterium rhinotracheale.
English: The only significant differences between the conduct of the 1999 and 2011 studies were with the age and weight of the birds used.
Croatian: Jedine značajne razlike između ispitivanja provedenih 1999. godine i 2011. godine odnosile su se na dob i masu korištenih ptica.
English: Therefore, the MAH concluded that the 1999 study should be disregarded and only the results of the 2011 study should be taken into account in establishing a withdrawal period, as these also correspond with the conclusions drawn in relation to other marketed products.
Croatian: Stoga, nositelj odobrenja za stavljanje u promet zaključuje da ispitivanje provedeno 1999. godine valja zanemariti, te da se samo rezultati iz 2011. godine moraju uzeti u obzir pri utvrđivanju karencije, s obzirom da isti odgovaraju zaključcima donesenima u odnosu na proizvode stavljene u promet.
English: In this case, where comparison is made between a product containing tartaric acid and another containing citric acid, and a formulation effect cannot be excluded due to the unknown impact of tartaric acid in the intestine, bioequivalence would have to be established through in vivo studies.
Croatian: U ovom slučaju, kada je napravljena usporedbu između proizvoda koji sadrže tartarnu kiselinu i ostalih proizvoda koji sadrže limunsku kiselinu, te kada nije moguće isključiti djelotvornost formulacije zbog nepoznatog učinka tartarne kiseline u debelom crijevu, biološka ekvivalentnost morala bi se ustvrditi na temelju in vivo ispitivanja.
English: In fact, by using a range of chickens with different ages and weights would allow for both faster and slower growing broiler breeds to be included in the derivation of the meat withdrawal period.
Croatian: Naime, korištenjem pilića različite dobi i mase dozvolilo bi se uključivanje brže i sporije rastućih brojlerskih pasmina u derivaciju karencije za meso.
English: Name
Croatian: Naziv
English: As to the comparison to other powders for use in drinking water containing doxycycline it is not possible to extrapolate the kinetics of doxycycline from the powders for use in drinking water containing doxycycline and citric acid to Soludox.
Croatian: Vezano uz usporedbu ostalih prašaka za uporabu u vodi za piće koji sadrže doksiciklin, nije moguće ekstrapolirati kinetiku doksiciklina od prašaka koji se koriste u vodi za piće koja sadrži doksiciklin i limunsku kiselinu u odnosu na Soludox.
English: The animals were given the correct dose and the product was administered appropriately and sufficient numbers of animals were used.
Croatian: Životinjama je dana ispravna doza i proizvod je ispravno dan, te je korišten dovoljan broj životinja.
English: The current CVMP guidance on the establishment of withdrawal periods had to be taken into account.
Croatian: U obzir su morale biti uzete aktualne smjernice za utvrđivanje karencije CVMP-a.
English: However, due to the legal basis of the variation application under consideration, the MAH had provided their own residue depletion data to support a withdrawal period and only these data must be considered.
Croatian: No, zbog pravnih temelja za predmetnu prijavu izmjene, nositelj odobrenja za stavljanje u promet dostavio je svoje vlastite podatke za depleciju rezidua u potvrdu razdoblja karencije tako da se samo ovi podaci smiju uzeti u razmatranje.
English: Following the CVMP opinion of 7 March 2013 recommending a 9 days withdrawal period for chicken meat and offal following a dose rate of 20 mg/kg body weight for 4 consecutive days, on 22 March 2013, Eurovet Animal Health BV notified the Agency of their intention to request a re-examination of the CVMP opinion.
Croatian: Nakon donošenja mišljenja CVMP-a od 7. ožujka 2013., kojim se preporuča karencija za pileće meso i iznutrice u trajanju od 9 dana nakon doze od 20 mg/kg tjelesne mase kroz 4 uzastopna dana, dana 22. ožujka 2013. godine društvo Eurovet Animal Health BV obavijestilo je Agenciju o svojoj namjeri podnošenja zahtjeva za ponovno ispitivanje mišljenja CVMP-a.
English: Marketing authorisation holder
Croatian: Nositelj odobrenja za stavljanje u promet