FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH is of the view that the efficacy of ciclosporin in bone marrow transplantation and GVHD is well established from the data in the original MAA, published clinical studies and extensive clinical use.
Croatian: GVHD-a dobro utvrđena na temelju podataka iz izvornog zahtjeva za odobrenje za stavljanje lijeka u promet, objavljenih kliničkih ispitivanja i opsežne kliničke uporabe.
English: General monitoring of posology.
Croatian: Opće praćenje doziranja.
English: Non-transplantation indications:
Croatian: Netransplantacijske indikacije:
English: In the original Sandimmun studies, initial doses in the range 14-18 mg/kg/day have been used and these were subsequently reduced to a maintenance dose in the range 6-10 mg/kg/day.
Croatian: mg/kg/dana, te su iste naknadno smanjene na dozu održavanja u rasponu od 6-10 mg/kg/dan.
English: The MAH proposed a new general wording to introduce the paragraph on non- transplantation indications, as general recommendations.
Croatian: Kao općenite preporuke, nositelj odobrenja predložio je novu općenitu formulaciju kao uvod u paragraf o netransplantacijskim indikacijama.
English: The CHMP was in agreement with this approach and related wordings as proposed by the MAH.
Croatian: CHMP suglasan je s ovim pristupom i povezanom formulacijom u skladu s prijedlogom nositelja odobrenja.
English: • Bone marrow transplantation
Croatian: • Transplantacija koštane srži
English: In conclusion, based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon and adopted harmonised sets of PI documents for the various presentations of Sandimmun Neoral and associated names.
Croatian: List of Outstanding Issues) i nakon razmatranja Povjerenstva, CHMP je suglasan s i prihvatio je usklađene komplete dokumenata informacija o lijeku za različite oblike lijeka Sandimmun Neoral i povezane nazive.
English: The MAH addressed the CHMP's concerns; the CHMP is of the view that clinical experience supports the proposed additions in the indication.
Croatian: Mišljenje je CHMP-a da kliničko iskustvo podupire predložene dopune u indikaciji.
English: However the statement “The daily doses of Neoral should always be given in two divided doses” was partly endorsed by the CHMP since the word “always” should be omitted (in some cases, three times daily administration may be needed).
Croatian: „uvijek“ treba biti izostavljena (u određenim je slučajevima potrebno uzimati lijek tri puta na dan).
English: The MAH's proposed indication wording for rheumatoid arthritis is approved in 13 EU countries.
Croatian: Formulacija indikacije za reumatoidni artritis predložena od strane nositelja odobrenja odobrena je u 13 država EU.
English: Based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon a harmonised wording of the section 4.2 accordingly for the special populations.
Croatian: List of Outstanding Issues) te po završetku rasprave Povjerenstva, CHMP usuglasio je prema tome usklađenu formulaciju djela 4.2 za posebne populacije.
English: The proposed wording was reviewed and agreed accordingly.
Croatian: Predložena formulacija je pregledana i prema tome usuglašena.
English: The CHMP also requested the MAH to provide more detailed information that could help the dose adjustments.
Croatian: CHMP također je zatražio od nositelja odobrenja da dostavi detaljnije informacije,
English: The CHMP agreed with the addition proposed by the MAH.
Croatian: CHMP složio se s dodatkom kojeg je predložio nositelj odobrenja.
English: The efficacy of Sandimmun (oil based formulation of ciclosporin) has been demonstrated in 4 randomized controlled and 5 uncontrolled studies.The clinical results from these 9 clinical studies were analyzed using a pooling of data from all studies (controlled and uncontrolled).
Croatian: Klinički rezultati ovih 9 kliničkih ispitivanja analizirani su ispitivanjem podataka iz svih ispitivanja (kontroliranih i nekontroliranih).
English: Similarly to the section 4.2, wordings for each of the sub-sections for the different non-transplantation indications were discussed and agreed between the CHMP and MAH.
Croatian: Slično kao u slučaju djela 4.2, CHMP i nositelj odobrenja raspravili su i usuglasili formulacije za svaki poddio za različite netransplantacijske indikacije.
English: The MAH accepted the proposal to amend the ADRs as highlighted by the CHMP.
Croatian: Nositelj odobrenja prihvatio je prijedlog da dopuni nuspojave kako je istaknuo CHMP.
English: The MAH proposed a wording for recommendations related to the switch between Sandimmun and Sandimmun Neoral in accordance with the approved wording of 9 countries.
Croatian: Sandimmun i lijeka Sandimmun Neoral u skladu s odobrenom formulacijom u 9 država.
English: Considering the narrow therapeutic window for ciclosporin, the CHMP requested the MAH to consider ciclosporin intake in order to reduce intra-individual variability.
Croatian: zatražio je od nositelja odobrenja da razmotri unos ciklosporina kako bi se smanjila intraindividualna varijabilnost.
English: The CHMP is of the view that introducing Sandimmun Neoral for the treatment of rejection is most appropriate for cellular rather than humoral rejection, based on the mechanism of action of CNI's.
Croatian: Na temelju mehanizma djelovanja CNI-a, mišljenje je CHMP-a da je uvođenje lijeka Sandimmun Neoral u liječenje odbacivanja najprimjerenije za stanično, a ne za humoralno odbacivanje.
English: The MAH agreed with the CHMP's opinion and a wording was agreed accordingly.
Croatian: Nositelj odobrenja suglasan je s mišljenjem CHMP-a, te je prema tome usuglašena formulacija.
English: Based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon a harmonised wording of the section 4.2 accordingly for the non-transplantations indications.
Croatian: List of Outstanding Issues) te po završetku rasprave Povjerenstva, CHMP usuglasio je prema tome usklađenu formulaciju djela 4.2 za netransplantacije.
English: As recorded in the minutes of the prereferral meeting held on 27 July 2011, regarding the approach to label harmonisation, the Agency agreed with the MAH's proposal to use the SmPC wording that is common in the majority of the Members States, the Sandimmun and Sandimmun Neoral CDSs as justified by the review of legacy studies and literature references.
Croatian: Agencija se složila s prijedlogom nositelja da se upotrijebi formulacija sažetka opisa svojstava lijeka koja je uobičajena u većini država članica, CDS-ovi lijekova Sandimmun i Sandimmun Neoral kako je opravdano pregledom naslijeđenih ispitivanja i bibliografskim referencama.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Sandimmum and associated names (see Annex I).
Croatian: • sažetak opisa svojstava lijeka, naljepnica i uputa o lijeku, koje su predložili nositelji odobrenja, ocijenjeni su na temelju dostavljene dokumentacije i znanstvenog razmatranja unutar Povjerenstva
English: Thus, a wording was proposed by the MAH and agreed by the CHMP to address this matter.
Croatian: No, nositelj odobrenja predložio je formulaciju, a CHMP je suglasan da se oslovi ovo pitanje.
English: Section 4.8 - Undesirable Effects
Croatian: Dio 4.8 - Nuspojave
English: The MAH agrees with the CHMP's view.
Croatian: Nositelj odobrenja suglasan je s mišljenjem CHMP
English: Section 6.3 - Shelf life
Croatian: Dio 6.3 - Rok valjanosti
English: The CHMP agreed with the wording proposed by the MAH.
Croatian: CHMP složio se s formulacijom koju je predložio nositelj odobrenja.
English: A revised wording was proposed by the MAH accordingly and endorsed by the CHMP.
Croatian: Prema tome, nositelj odobrenja predložio je revidiranu formulaciju, koju je CHMP potvrdio.
English: Therefore, based on clinical data summary on atopic dermatitis and references provided by the MAH, the CHMP considers the argumentation made by the MAH acceptable and therefore agrees with the above mentioned wording.
Croatian: Stoga, na temelju sažetka kliničkih podataka o atopičkom dermatitisu i referencama navedenima od strane nositelja odobrenja,
English: The CHMP was of the view that the proposed text is relevant to include and therefore the CHMP agreed with the wordings as proposed by the MAH.
Croatian: Mišljenje je CHMP-a da je važno uključiti predloženi tekst, te je stoga CHMP
English: The approach taken by the MAH to achieve a proposed harmonized SmPC with regard to the safety sections of the SmPC (sections 4.3 to 4.9) was to use as a basis the most recently updated MAH's Core Data Sheet (CDS) of Sandimmun Neoral, dated 13 February 2012 (as justified by a review of submitted legacy studies, and identified literature references) and the finalized Core Safety profile (CSP) from the last PSUR 13 work sharing (WS) procedure (EE/H/PSUR/0007/001).
Croatian: Sheet) nositelja odobrenja za lijek Sandimmun Neoral, od dana 13. veljače 2012. godine (kako je opravdano pregledom dostavljenih naslijeđenih ispitivanja i identificiranim bibliografskim referencama) te završnog Sigurnosnog profila lijeka (CSP, Core Safety Profile) iz posljednjeg 13.
English: However, in case of a more prolonged inability to use oral ciclosporin, use of IV ciclosporin should be considered, provided that care is taken to administer an adequate IV dose.
Croatian: potrebno je razmotriti intravenoznu primjenu ciklosporina, ukoliko su poduzete mjere za primjenu primjerene intravenozne doze.
English: ” This wording was endorsed by the CHMP.
Croatian: CHMP odobrio je ovu formulaciju.
English: The CHMP therefore agreed with the approach taken by the MAH.
Croatian: Stoga je CHMP suglasan s pristupom nositelja odobrenja.
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Croatian: Razlozi za dopunu sažetka opisa svojstava lijeka, naljepnice i upute o lijeku
English: Sandimmun Neoral was first registered in Germany in February 1993 and is available in the EU as 10 mg, 25 mg, 50 mg, 100 mg soft gelatin capsules and 100 mg/ml oral solution.
Croatian: EU kao 10 mg, 25 mg, 50 mg, 100 mg mekane želatinaste kapsule i 100 mg/ml oralna otopina.
English: The dossier of
Croatian: Dosje lijeka
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Croatian: Budući da • predmet ovog upućivanja je usklađivanje sažetka opisa svojstava lijeka, naljepnice i upute o lijeku
English: This point was addressed by the MAH and a wording was agreed.
Croatian: Nositelj odobrenja riješio je ovo pitanje, te je formulacija usuglašena.
English: The daily doses of Neoral should always be given in two divided doses.” The MAH's statement “The dose ranges given for oral administration are intended to serve as guidelines only” is endorsed by the CHMP.
Croatian: CHMP potvrdio je izjavu nositelja odobrenja „Rasponi doze navedeni za oralnu primjenu predviđeni su samo kao smjernice“.
English: To achieve a harmonized SmPC, the MAH used the wording that is common to national SmPCs in the majority of MSs and the MAH's Core Data Sheet (CDS) for Sandimmun Neoral (dated 13 February 2012), as well as submitted legacy studies and literature references.
Croatian: Da bi se postigli usklađeni Sažetci opisa svojstava lijeka, nositelj odobrenja za stavljanje lijeka u promet upotrijebio je formulacije, koje su uobičajene za nacionalne Sažetke opisa svojstava lijeka u većini država članica, i Listu ključnih podataka (CDS, engl.
English: The CHMP is in agreement with the MAH's position.
Croatian: CHMP suglasan je s mišljenjem nositelja odobrenja.
English: The proposed wording was acceptable to the CHMP.
Croatian: CHMP prihvatio je predloženu formulaciju.
English: The CHMP was in agreement with the approach taken by the MAH.
Croatian: CHMP suglasan je s pristupom nositelja odobrenja.
English: The MAH agreed with the CHMP's opinion and hence revised the wording of the posology in the solid organ transplantation indication accordingly.
Croatian: a, te je prema tome revidirao formulaciju o doziranju za indikaciju transplantacije organa.
English: The CHMP was in agreement with the MAH's proposal.
Croatian: CHMP suglasan je s prijedlogom nositelja odobrenja.
English: The recommended dose is…
Croatian: Preporučena doza je...
English: Find a comfortable, well-lit place.
Croatian: Nađite udobno i dobro osvijetljeno mjesto.
English: - Uncontrolled hypertension.
Croatian: - Nekontrolirana hipertenzija.
English: Please discuss this with your doctor.
Croatian: O tome razgovarajte sa svojim liječnikom.
English: Date of first authorisation: 23 October 2009.
Croatian: Datum prvog odobrenja: 23. listopada 2009.
English: The safety and efficacy of Biopoin in children and adolescents aged up to 17 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Biopoin u djece i adolescenata u dobi do 17 godina nisu još ustanovljene.
English: Do not give this medicine to children and adolescents under 18 years of age because there are no data that show that this medicine is safe and works in this age group.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina jer nema podataka koji pokazuju da je ovaj lijek siguran i da djeluje u ovoj dobnoj skupini.
English: Your doctor or nurse will give you instructions on how to do this.
Croatian: Liječnik ili medicinska sestra će Vam dati odgovarajuće upute kako da to učinite.
English: Proper treatment of your disease, however, requires close and constant co-operation with your doctor.
Croatian: Pravilno liječenje bolesti, međutim, zahtijeva blisku i stalnu suradnju s liječnikom.
English: Very rare: Not known:
Croatian: Vrlo rijetko: Nepoznato:
English: Furthermore, deaths were more frequent in this patient group compared to younger patients.
Croatian: Nadalje, smrtni slučajevi bili su češći u toj skupini bolesnika u usporedbi s mlađim bolesnicima.
English: End of 7 days period at room temperature: __/__/____
Croatian: Istek razdoblja od 7 dana na sobnoj temperaturi: __/__/____
English: Do not warm Biopoin in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Biopoin ni na koji drugi način (npr. ne zagrijavajte ga u mikrovalnoj pećnici ili u vrućoj vodi).
English: Date of latest renewal: 26 August 2014.
Croatian: Datum posljednje obnove odobrenja: 26. kolovoz 2014.
English: This can help to provide more information on the safety of medicines like this one.
Croatian: To može pomoći u prikupljanju više informacija o sigurnosti ovakvih lijekova.
English: - Severely elevated blood pressure:
Croatian: - Izrazito povišen krvni tlak:
English: - if you have high blood pressure that cannot be controlled.
Croatian: - ako imate povišeni krvni tlak koji se ne može kontrolirati.
English: cannot be estimated from the available data.
Croatian: ne može se procijeniti iz dostupnih podataka.
English: It works in exactly the same way as erythropoietin.
Croatian: Djeluje na isti način kao i eritropoetin.
English: Treatment with Biopoin is divided into two stages: a) Correcting the anaemia
Croatian: Liječenje lijekom Biopoin podijeljeno je u dvije faze: a) Korekcija anemije
English: It acts as a mitosis-stimulating factor and differentiation hormone.
Croatian: Djeluje kao faktor koji stimulira mitozu i kao hormon diferencijacije.
English: Healthy people should not use Biopoin.
Croatian: Zdrave osobe ne smiju uzimati Biopoin.
English: Before you stop using this medicine, talk to your doctor.
Croatian: Prije nego prestanete uzimati ovaj lijek, razgovarajte sa svojim liječnikom.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine.
Croatian: Važno je da obavijestite svog liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate trudnoću jer bi liječnik u tom slučaju mogao odlučiti ne propisati Vam ovaj lijek.
English: Do not increase the dose your doctor has given you.
Croatian: Nemojte povećavati dozu koju Vam je propisao liječnik.
English: Red blood cells are very important for distributing oxygen within your body.
Croatian: Crvene krvne stanice su vrlo važne za raspodjelu kisika u organizmu.
English: These symptoms could indicate that your treatment with this medicine is ineffective.
Croatian: Ti simptomi mogu upućivati na činjenicu da liječenje ovim lijekom nije djelotvorno.
English: It is recommended that haemoglobin be monitored every two weeks until levels have stabilised and periodically thereafter.
Croatian: Preporučuje se kontrola hemoglobina svaka dva tjedna dok se vrijednosti ne stabiliziraju te periodično nakon toga.
English: Epoetin theta is a protein produced by biotechnology.
Croatian: Epoetin theta je protein proizveden biotehnologijom.
English: The initial dose is 20,000 IU.
Croatian: Početna doza je 20 000 IU.
English: Particular attention should be paid to sudden sharp migraine-like headaches as a possible warning signal.
Croatian: Posebnu pažnju treba posvetiti naglim oštrim glavoboljama nalik migreni, kao mogućem znaku upozorenja.
English: Other medicines and Biopoin
Croatian: Drugi lijekovi i Biopoin
English: This leaflet was last approved in .
Croatian: Uputa je zadnji puta odobrena u.
English: b) Maintaining sufficient red blood cell levels
Croatian: b) Održavanje dostatnih koncentracija crvenih krvnih stanica
English: Epoetins are not indicated for use in this patient population.
Croatian: Epoetini nisu indicirani za uporabu kod te skupine bolesnika.
English: Following intravenous administration, the volume of distribution approximates to total blood volume.
Croatian: Nakon intravenske primjene, volumen distribucije približno je isti ukupnom volumenu krvi.
English: Do not attempt to give this medicine to yourself without this training.
Croatian: Nemojte pokušavati sami sebi dati ovaj lijek bez da ste dobili upute.
English: Hypertension can be treated with appropriate medicinal products (see section 4.4).
Croatian: Hipertenzija se može liječiti odgovarajućim lijekovima (vidjeti dio 4.4).
English: Laboratory monitoring
Croatian: Laboratorijska kontrola
English: Correction phase
Croatian: Faza korekcije
English: You may notice small air bubbles in the pre-filled syringe.
Croatian: Možda ćete primijetiti male mjehuriće zraka u napunjenoj štrcaljki.
English: Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of epoetins and should therefore be corrected.
Croatian: Manjak željeza, folne kiseline ili vitamina B12 smanjuje učinkovitost epoetina i stoga ta stanja treba korigirati.
English: Your blood pressure needs to be checked closely before and during treatment with this medicine.
Croatian: Vaš krvni tlak treba pažljivo kontrolirati prije i tijekom liječenja ovim lijekom.
English: The safety of epoetin theta has been evaluated based on results from clinical studies including 972 patients.
Croatian: Sigurnost epoetina theta procijenjena je na temelju rezultata kliničkih ispitivanja u kojima su sudjelovala 972 bolesnika.
English: - Do not put the cover back on used needles.
Croatian: Ne vraćajte poklopac na upotrijebljene igle.
English: Approximately 9% of patients can be expected to experience an adverse reaction.
Croatian: Nuspojave se mogu očekivati u oko 9% bolesnika.
English: Contents of the pack and other information What Biopoin contains
Croatian: Sadržaj pakiranja i druge informacije Što Biopoin sadrži
English: Do not use it if the date has passed the last day of the month shown.
Croatian: Lijek nemojte primijeniti ako je istekao posljednji dan navedenog mjeseca.
English: The maximum concentration is reached after an average of 10 to 14 hours and the average terminal half-life ranges from approximately 22 to 41 hours.
Croatian: Najviša koncentracija dostignuta je u prosjeku nakon 10 do 14 sati, a prosječni terminalni poluvijek kreće se od oko 22 do 41 sata.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek primjenite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
English: Anaemia occurs when your blood does not contain enough red blood cells.
Croatian: Anemija se javlja kad krv ne sadrži dovoljan broj crvenih krvnih stanica.
English: - Never put the syringes that you have used into your normal household rubbish bin.
Croatian: - Iskorištene štrcaljke nikada ne odlažite u uobičajeni kućni koš za smeće.
English: During the studies, mortality was lower in the epoetin theta group (6.9%) compared to placebo (10.3%).
Croatian: Tijekom ispitivanja mortalitet je bio niži u skupini koja je primala epoetin theta (6,9%) u odnosu na skupinu koja je primala placebo (10,3%).
English: This is known as a subcutaneous injection.
Croatian: To je poznato kao supkutana injekcija.
English: Your treatment with this medicine is being initiated by a doctor who is experienced in the above-mentioned indications.
Croatian: Vaše liječenje ovim lijekom započet će liječnik s iskustvom u gore navedenim indikacijama.
English: Your healthcare professional will always record the exact product you are using.
Croatian: Vaš će liječnik uvijek zapisati koji točno lijek primjenjujete.
English: *See subsection “Description of selected adverse reactions” below
Croatian: *Vidjeti niže odjeljak „Opis odabranih nuspojava“
English: It is unlikely to be serious.
Croatian: Međutim, to ne bi trebalo uzrokovati ozbiljne probleme.
English: If you are already taking a medicine to reduce your blood pressure, your doctor might increase the dose.
Croatian: Ako već uzimate lijekove za snižavanje krvnog tlaka, liječnik može povećati njihovu dozu.
English: It may also be necessary to reduce your dose of Biopoin or to stop the treatment with Biopoin for a short period of time.
Croatian: Možda će biti potrebno i smanjiti Vašu dozu lijeka Biopoin ili prekinuti liječenje lijekom Biopoin na kraće vrijeme.
English: Treatment with epoetin theta is divided into two stages.
Croatian: Liječenje epoetinom theta podijeljeno je u dvije faze.
English: As a precautionary measure, it is preferable to avoid the use of Biopoin during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Biopoin tijekom trudnoće.
English: Skin reactions*
Croatian: Kožne reakcije*
English: Therapy should be continued up to 4 weeks after the end of chemotherapy.
Croatian: Terapiju treba nastaviti do 4 tjedna nakon kraja kemoterapije.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Croatian: U četiri placebom kontrolirana ispitivanja omjeri rizika ukupnog preživljavanja bili su između 1,25 i 2,47 u korist kontrolne skupine.
English: What you should do before your injection
Croatian: Što trebate učiniti prije primjene injekcije
English: It is better to change the injection site every day to avoid the risk of soreness at any one site.
Croatian: Dobro je svakodnevno mijenjati mjesto primjene kako bi se izbjegao rizik od boli na bilo kojem mjestu primjene.
English: The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Croatian: Ciljna koncentracija hemoglobina u dva ispitivanja bila je > 13 g/dl; u ostala tri ispitivanja bila je 12 - 14 g/dl.
English: - if you are allergic to epoetin theta, another epoetin or any of the other ingredients of this medicine (listed in section 6);
Croatian: - ako ste alergični na epoetin theta, neki drugi epoetin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: This may be associated with life-threatening cardiovascular complications.
Croatian: To može biti povezano s kardiovaskularnim komplikacijama opasnima po život.
English: Check the appearance of Biopoin.
Croatian: Provjerite izgled lijeka Biopoin.