FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee recommended that Ivabradine Accord be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Ivabradine Accord u EU-u.
English: It is not intended to provide practical advice on how to use Ivabradine Accord.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Ivabradine Accord.
English: What is Ivabradine Accord and what is it used for?
Croatian: Što je Ivabradine Accord i za što se koristi?
English: For practical information about using Ivabradine Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Ivabradine Accord bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: What are the benefits and risks of Ivabradine Accord?
Croatian: Koje su koristi i rizici od lijeka Ivabradine Accord?
English: Other information about Ivabradine Accord
Croatian: Ostale informacije o lijeku Ivabradine Accord
English: Therefore, the CHMP's view was that, as for Procoralan, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da koristi nadmašuju utvrđene rizike, kao i kod lijeka Procoralan.
English: The active substance in Ivabradine Accord, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' that regulates the heart rate.
Croatian: Ivabradin, djelatna tvar u lijeku Ivabradine Accord, blokira ‘If struju' u sinusnom čvoru, prirodnom elektrostimulatoru koji regulira puls.
English: Ivabradine Accord contains the active substance ivabradine.
Croatian: Ivabradine Accord sadrži djelatnu tvar ivabradin.
English: Why is Ivabradine Accord approved?
Croatian: Zašto je Ivabradine Accord odobren?
English: How does Ivabradine Accord work?
Croatian: Kako djeluje Ivabradine Accord?
English: How is Ivabradine Accord used?
Croatian: Kako se Ivabradine Accord koristi?
English: How has Ivabradine Accord been studied?
Croatian: Kako je Ivabradine Accord ispitivan?
English: • There were also deviations from the final protocol and statistical analysis plan.
Croatian: • Također su postojala odstupanja od završnog protokola i plana statističke analize.
English: Distribution and elimination
Croatian: Distribucija i eliminacija
English: Bio-Set System:
Croatian: Bio-Set sustav:
English: Repeat every 12 to 24 hours.
Croatian: Ponoviti svakih 12 do 24 sata.
English: The required dose is determined using the following formulae:
Croatian: Potrebna doza određuje se sljedećim formulama:
English: • Risk Management plan (RMP)
Croatian: Plan upravljanja rizicima (RMP)
English: Wash your hands thoroughly using soap and warm water.
Croatian: Temeljito operite ruke sapunom i toplom vodom.
English: 20024 Garbagnate Milanese (MI) Italy
Croatian: 20024 Garbagnate Milanese (MI) Italija
English: Minor including tooth extraction
Croatian: Manji uključujući vađenje zuba
English: Date of latest renewal: 06 August 2010
Croatian: Datum posljednje obnove: 6. kolovoza 2010.
English: An updated RMP should be submitted:
Croatian: Nadalje, nadopunjen RMP treba dostaviti:
English: Check with your doctor, pharmacist or nurse if you are not sure.
Croatian: Provjerite s Vašim liječnikom ili ljekarnikom ako niste sigurni.
English: Rare / not known
Croatian: Vrlo rijetko / nepoznato
English: This indicates that the system is activated (D).
Croatian: Time se sustav aktivira (D).
English: The material should not be warmer than body temperature (not exceed 37 °C).
Croatian: Materijal ne smije biti topliji od tjelesne temperature (ne više od 37 °C).
English: Please consult your doctor immediately.
Croatian: Molimo odmah se obratite liječniku.
English: Not known (frequency cannot be estimated from the available data): • dysgeusia (strange taste)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) • disgeuzija (čudan okus)
English: The solution must be prepared on a clean and dry surface.
Croatian: Otopina se mora pripremati na čistoj i suhoj površini.
English: The relevance for clinical practice in the EU (and therefore for the products subject to this procedure) is therefore questioned.
Croatian: Stoga je upitna relevantnost za kliničku praksu u EU-u (prema tome i za lijekove koji podliježu tom postupku).
English: • Treatment regimens in EU are different from those in the SIPPET study.
Croatian: • Režimi liječenja u EU-u razlikuju se od onih u ispitivanju SIPPET.
English: Package Leaflet: Information for the user
Croatian: Uputa o lijeku: Informacija za korisnika
English: This must be checked by an experienced doctor.
Croatian: To mora provjeriti liječnik s iskustvom.
English: Laboratory tests
Croatian: Laboratorijski testovi
English: The experts emphasized that collaboration between academia, industry and regulators should be encouraged to collect harmonised data through registries.
Croatian: Stručnjaci su istaknuli da treba poticati suradnju između akademske zajednice, industrijskog sektora i regulatora kako bi se putem registara prikupili usklađeni podatci.
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju pojave šoka potrebno je provesti standardno liječenje šoka.
English: • if you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).
Croatian: • ako ste alergični na oktokog alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6 i na kraju dijela 2)
English: The expert group was of the view that the relevant available data sources have been considered.
Croatian: Mišljenje stručne skupine bilo je da su razmotreni relevantni i dostupni izvori podataka.
English: • the factor VIII level that is needed.
Croatian: • potrebna razina faktora VIII.
English: These factors make control of such studies and interpretation of the results challenging.
Croatian: Ti čimbenici stvaraju poteškoće u kontroli takvih ispitivanja i tumačenju rezultata.
English: The safety and efficacy of {(Invented) name} in previously untreated patients have not yet been established.
Croatian: Sigurnost i djelotvornost {(Novoizumljeno) ime} u prethodno neliječenih bolesnika nisu još ustanovljene.
English: OTHER Bayer-Logo
Croatian: DRUGO Bayer-Logo
English: The PRAC adopted a recommendation on 01 September 2017 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Croatian: PRAC je 1. rujna 2017. usvojio preporuku koju je zatim razmatrao CHMP u skladu s člankom 107. točkom (k) Direktive 2001/83/EZ.
English: Therefore, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svome liječniku za savjet prije nego uzmete ovaj lijek.
English: Powder: dry white to slightly yellow powder or cake.
Croatian: Prašak: suhi bijeli do žućkasti prašak ili kolačić.
English: If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor.
Croatian: Ako imate osjećaj da je učinak ovog lijeka prejak ili preslab, obratite se liječniku.
English: Immune Tolerance Induction (ITI)
Croatian: Izazivanje imunološke tolerancije (ITI)
English: Desired plasma FVIII level
Croatian: Željena razina FVIII u plazmi
English: This association was consistently observed in multivariable analysis.
Croatian: Ta je povezanost dosljedno zabilježena u multivarijabilnoj analizi.
English: Bayer Corporation (license holder) Bayer HealthCare LLC 800 Dwight Way
Croatian: Bayer Corporation (nositelj licence) Bayer HealthCare LLC 800 Dwight Way
English: Repeat infusion every 8 to 24 hours until threat is resolved
Croatian: Ponoviti infuziju svakih 8 do 24 sata dok se ne ukloni opasnost
English: However, please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Svejedno, obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: This medicine must not be mixed with other infusion solutions.
Croatian: Ovaj se lijek ne smije miješati s drugim infuzijskim otopinama.
English: PRAC discussion on grounds for re-examination
Croatian: Rasprava PRAC-a o razlozima za preispitivanje
English: Frequencies have been evaluated according to the following convention: very common: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost je procijenjena prema sljedećoj konvenciji: vrlo često: (≥1/10), (često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Interactions with other medicines are not known.
Croatian: Nisu poznate interakcije s drugim lijekovima.
English: Infusion related febrile reaction (pyrexia)
Croatian: Febrilna reakcija povezana s infuzijom (pireksija)
English: The PRAC consulted an ad-hoc expert meeting on some of the aspects that formed part of the detailed grounds submitted by LFB Biomedicaments.
Croatian: PRAC se savjetovao na ad hoc sastanku stručne skupine o nekim aspektima koji su bili dio detaljnih razloga koje je podnio LFB Biomedicaments.
English: 2 http://www.bloodjournal.org/content/109/11/4648.full.pdf 3 Gouw SC et al. PedNet and RODIN Study Group.
Croatian: 2 http://www.bloodjournal.org/content/109/11/4648.full.pdf 3 Gouw SC et al.
English: Table 2: Example for calculation of infusion rate for continuous infusion after initial bolus injection
Croatian: Tablica 2: Primjer izračuna brzine infuzije za kontinuiranu infuziju nakon početne bolus injekcije
English: Data have been obtained from clinical studies in 61 children under 6 years of age and non-interventional studies in children of all ages.
Croatian: Podaci su dobiveni iz kliničkih ispitivanja provedenih na 61 djetetu mlađem od 6 godina te neintervencijskih ispitivanja djece svih dobi.
English: Although this became non-significant when UK patients (also included in the RODIN/Pednet study were excluded.
Croatian: No to je postalo beznačajno nakon što su isključeni bolesnici iz Ujedinjene Kraljevine (također obuhvaćeni ispitivanjem RODIN/Pednet).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja lijeka u primjeni i uvjeti prije primjene odgovornost su korisnika.
English: For products for which section 4.2 contains the following statement for PUPs: “<Previously untreated patients.
Croatian: Za lijekove kod kojih je u dijelu 4.2. za prethodno neliječene bolesnike navedena sljedeća izjava: „< Prethodno neliječeni bolesnici.
English: Every 24 hours, at least 1 day, until healing is achieved.
Croatian: Svaka 24 sata, tijekom najmanje jednog dana, do zacjeljivanja.
English: Furthermore, over time there have been changes in manufacturing process of individual products and changes in treatment regimens between centres, hence “like for like” comparisons between products is not always possible.
Croatian: Nadalje, tijekom vremena došlo je do promjena u proizvodnim procesima pojedinih lijekova i promjena u režimima liječenja između centara, stoga isti uvjeti usporedbe lijekova nisu uvijek mogući.
English: The available data showed that in many studies including the EUHASS registry (Iorio A, 20174; Fischer K, 20155) the frequency could be classified as “uncommon”.
Croatian: Dostupni podatci pokazali su da se u brojnim ispitivanjima, uključujući registar EUHASS (Iorio A, 20174; Fischer K, 20155), učestalost može razvrstati kao „manje česta”.
English: Prevention of bleeding
Croatian: Prevencija krvarenja
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Croatian: Trombin zatim pretvara fibrinogen u fibrin i omogućuje stvaranje ugruška.
English: Frequency of doses (hours)/ Duration of therapy (days)
Croatian: Učestalost primjene (sati) / trajanje liječenja (dani)
English: However, in many cases little information was provided on the methods, patient populations and nature of the inhibitors to assess the information in the context of more recent published data.
Croatian: Međutim, u mnogo slučajeva dostavljene su nedostatne informacije o metodama, populacijama bolesnika i prirodi inhibitora da bi se informacije mogle ocijeniti u kontekstu podataka objavljenih u skorije vrijeme.
English: Do not touch the syringe tip with your hand or any surface.
Croatian: Vrh štrcaljke nemojte dirati rukom ni bilo kojom drugom površinom.
English: A retrospective review has been done on 40 patients, and 39 patients were included in a prospective investigator-initiated clinical study.
Croatian: Retrospetktivno ispitivanje provelo se u 40 bolesnika, a 39 bolesnika bilo je uključeno u prospektivno kliničko ispitivanje na inicijativu ispitivača.
English: Clearance: 3 mL/h/kg
Croatian: Klirens: 3 ml/h/kg
English: Consequently, patients should be evaluated and monitored for cardiac risk factors.
Croatian: Posljedično, bolesnici se moraju procijeniti i pratiti za kardiološke faktore rizika.
English: Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code B02BD02.
Croatian: Farmakoterapijska skupina: antihemoragici: krvni koagulacijski faktor VIII, ATK oznaka B02BD02.
English: The lead authors of the SIPPET study were also invited to respond to a list of questions regarding the study methods and findings and to present their conclusions at the February 2017 PRAC plenary meeting.
Croatian: Vodeći autori ispitivanja SIPPET također su pozvani da odgovore na popis pitanja o metodama i nalazima ispitivanja te da svoje zaključke iznesu na plenarnoj sjednici PRAC-a u veljači 2017.
English: Factor VIII level required (%) (IU/dl)
Croatian: Potrebna razina faktora VIII (%) (IU/dl)
English: Rare (may affect up to 1 in 1,000 users):
Croatian: Rijetko (mogu se javiti u do 1 na 1000 korisnika)
English: For infusion, the product must be prepared under aseptic conditions.
Croatian: Lijek se za infuziju mora pripremiti u aseptičkim uvjetima.
English: PRAC also considered grounds submitted by LFB Biomedicaments as basis for their request for reexamination of the PRAC recommendation and the views of two experts meetings held on 22 February and 3 August 2017.
Croatian: PRAC je također razmotrio razloge koje je LFB Biomedicaments podnio kao osnovu zahtjeva za preispitivanje preporuke PRAC-a i stajališta iznesena na dvama sastancima stručne skupine održanima 22. veljače i 3. kolovoza 2017.
English: Clinical discussion
Croatian: Klinička rasprava
English: Now remove and discard the adapter housing (E).
Croatian: Sada uklonite i bacite kućište nastavka (E).
English: The reconstituted medicinal product is a clear and colourless solution.
Croatian: Rekonstituirani lijek je bistra i bezbojna otopina.
English: Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.
Croatian: U nekim okolnostima može biti potrebna primjena većih količina od izračunatih, a pogotovo prilikom početne doze.
English: The additional points of clarification provided by the SIPPET authors do not fully resolve this uncertainty.
Croatian: Dodatna pojašnjenja koja su pružili autori ispitivanja SIPPET nisu u potpunosti uklonila tu nesigurnost.
English: The PRAC also considered interim results submitted by the MAHs from ongoing studies from CSL (CRD019_5001) and Bayer (Leopold KIDS, 13400, part B.).
Croatian: PRAC je također razmotrio privremene rezultate koje su nositelji odobrenja za stavljanje u promet dostavili iz ispitivanja u tijeku koja provode CSL (CRD019_5001) i Bayer (Leopold KIDS, 13400, part B.).
English: The experts also suggested studies which could further characterise the immunogenic properties of the factor VIII medicinal products (e.g. mechanistic, observational studies).
Croatian: Stručnjaci su također predložili ispitivanja kojima bi se dodatno opisala imunogena svojstva lijekova s faktorom VIII (npr. mehanistička, opservacijska ispitivanja).
English: Patients with inhibitors
Croatian: Bolesnici s inhibitorima
English: These different manufacturing processes (including the different cell lines used to engineer the rFVIII products) can in theory lead to differential immunogenicity.
Croatian: Ti različiti proizvodni procesi (uključujući korištenje različitih staničnih linija za izrađivanje lijekova s rekombinantnim faktorom VIII) može teoretski dovesti do razlika u imunogenosti.
English: The specific activity of KOGENATE Bayer is approximately 4000 IU/mg protein.
Croatian: Specifična je aktivnost lijeka KOGENATE Bayer približno 4000 IU/mg proteina.
English: Ad hoc expert group meeting
Croatian: Ad hoc sastanak stručne skupine
English: The listed warnings and precautions apply both to adults and children.
Croatian: Navedena upozorenja i mjere opreza vrijede kako za odrasle, tako i za djecu.
English: • Treatment-related factors include intensity of exposure, number of exposure days (EDs), on demand treatment posing a greater risk than prophylaxis, particularly in the context of danger signals such as trauma or surgery, and young age at first treatment poses a higher risk.
Croatian: • Čimbenici povezani s liječenjem uključuju intenzitet izloženosti, broj dana izlaganja liječenju, veću rizičnost liječenja prema potrebi u odnosu na profilaksu, osobito u kontekstu signala opasnosti kao što je trauma ili kirurški zahvat, a prvo liječenje u mlađoj životnoj dobi predstavlja veći rizik.
English: In particular the skin related reactions may occur commonly, whereas a progress to severe anaphylaxis (including shock) is considered to be rare.
Croatian: Posebice se često mogu javiti reakcije povezane s kožom, dok se smatra da je napredovanje u tešku anafilaksiju (uključujući šok) rijetko.
English: These studies have yielded different results and suffer from the limitations of observational studies, and in particular from possible selection bias.
Croatian: Ta su ispitivanja imala različite rezultate te podliježu ograničenjima opservacijskih ispitivanja, osobito mogućoj pristranosti u odabiru.
English: Blood and the Lymphatic System Disorders
Croatian: Poremećaji krvi i limfnog sustava
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Croatian: Najmanje jedan dan dok se ne zaustavi krvarenje na koje upućuje bol ili do zacjeljenja.
English: This medicine is intended for injection into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after reconstitution.
Croatian: Ovaj lijek se primjenjuje injekcijom u venu tijekom 2 do 5 minuta, ovisno o ukupnom volumenu i Vašoj razini podnošljivosti te se treba primijeniti u roku od 3 h nakon pripreme otopine.
English: Solvent: water for injection, a clear, colourless solution.
Croatian: Otapalo: voda za injekciju, bistra, bezbojna otopina.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Croatian: Bolesnici se mogu razlikovati u odgovoru na faktor VIII, ispoljavajući različita poluvremena i povrate.
English: Water for injections
Croatian: Otapalo voda za injekcije
English: Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.
Croatian: Ponoviti infuziju svakih 12 - 24 sata tijekom 3 - 4 dana ili dulje do prestanka boli i tegoba.
English: KOGENATE Bayer can be infused by continuous infusion.
Croatian: KOGENATE Bayer može se infundirati kontinuiranom infuzijom.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for factor VIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se ili kao postotak (u odnosu na normalnu ljudsku plazmu) ili u međunarodnim jedinicama (u odnosu na međunarodni standard za faktor VIII u plazmi).
English: In patients where immune tolerance was achieved the bleedings could be prevented or controlled with KOGENATE Bayer again, and the patients could continue with prophylactic treatment as maintenance therapy.
Croatian: U bolesnika u kojih se postigla imunološka tolerancija, krvarenja su se ponovno mogla spriječiti ili kontrolirati pomoću lijeka KOGENATE Bayer, a bolesnici su mogli nastaviti s profilaktičkim liječenjem kao terapijom održavanja.
English: If you are using KOGENATE Bayer to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Croatian: Ako KOGENATE Bayer uzimate za prevenciju (profilaksu) krvarenja, liječnik će Vam izračunati potrebnu dozu.
English: As the evidence suggests that all human FVIII products carry a risk of inhibitor development such statements should be removed.
Croatian: Budući da dokazi ukazuju na to da kod svih lijekova s ljudskim faktorom VIII postoji rizik od razvoja inhibitora, takve izjave treba ukloniti.
English: Warnings and precautions Take special care with KOGENATE Bayer and talk to your doctor or pharmacist if:
Croatian: Upozorenja i mjere opreza Budite posebno oprezni s lijekom KOGENATE Bayer te se obratite svom liječniku ili ljekarniku ako:
English: The product contains traces of mouse and hamster proteins and human proteins other than factor VIII (see section 5.1).
Croatian: Lijek sadrži tragove proteina miša i hrčka te drugih ljudskih proteina osim faktora VIII (vidjeti dio 5.1).
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity.
Croatian: Izračun potrebne doze faktora VIII temelji se na empirijskim nalazima da 1 međunarodna jedinica (IU) faktora VIII po kg tjelesne težine povećava aktivnost faktora VIII u plazmi za 1,5% do 2,5% normalne aktivnosti.
English: - Known allergic reactions to mouse or hamster protein.
Croatian: - Alergijske reakcije na proteine miša ili hrčka.
English: Following the adoption of the PRAC recommendation during the May 2017 PRAC meeting, the MAH LFB Biomedicaments expressed their disagreement with the initial PRAC recommendation.
Croatian: Nakon donošenja preporuke PRAC-a tijekom sastanka u svibnju 2017., nositelj odobrenja za stavljanje u promet LFB Biomedicaments izrazio je neslaganje s početnom preporukom PRAC-a.
English: Given the detailed grounds provided by the MAH, the PRAC carried out a new assessment of the available data in the context of the re-examination.
Croatian: Uzimajući u obzir detaljne razloge koje je naveo nositelj odobrenja za stavljanje u promet, PRAC je proveo novu procjenu dostupnih podataka u kontekstu preispitivanja.
English: The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions.
Croatian: Kompleks faktora VIII/von Willebrandova faktora (vWF-a) sastoji se od dvije molekule (faktora VIII i vWF-a) različitih fizioloških funkcija.
English: If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately.
Croatian: U slučaju alergijske ili anafilaktičke reakcije injekciju/infuziju je potrebno odmah zaustaviti.
English: Continuous infusion
Croatian: Kontinuirana infuzija
English: If these components cannot be used, please contact your doctor.
Croatian: Ako se te komponente ne mogu koristiti, obratite se svom liječniku.
English: However, the general estimates of inhibitor rates from these studies for individual products are broadly in line with the findings from large observational studies.
Croatian: Međutim, opće procjene stopa pojave inhibitora iz tih ispitivanja pojedinačnih lijekova uglavnom su u skladu s nalazima velikih opservacijskih ispitivanja.
English: • nausea this can constitute an early warning for hypersensitivity and anaphylactic reactions.
Croatian: • mučninu to mogu biti prvi znakovi preosjetljivosti i anafilaktičkih reakcija.