FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Nonafact and what it is used for
Croatian: Što je Nonafact i za što se koristi
English: Your doctor will check your blood regularly for the presence of these antibodies.
Croatian: Liječnik će redovito pregledavati Vašu krv na prisutnost protutijela.
English: Required units = body weight (kg) x desired factor IX rise (%) (IU/dl) x 0.9
Croatian: Potrebne jedinice = tjelesna težina (kg) x željeni porast faktora IX (%) (IU/dl) x 0,9
English: In rare cases, Nonafact can give rise to a severe allergic reaction (anaphylactic shock).
Croatian: U rijetkim slučajevima Nonafact može prouzročiti tešku alergijsku reakciju (anafilaktički šok).
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Croatian: Faktor IX je jednolančani glikoprotein molekulske mase oko 68 000 Daltona.
English: Manufacturing also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Croatian: Proizvodnja također uključuje korake u obradi krvi ili plazme koji mogu deaktivirati ili ukloniti viruse.
English: The exact dose will depend on the seriousness of the clinical situation, your body weight and the amount of factor IX in your blood.
Croatian: Točna doza ovisit će o ozbiljnosti kliničke situacije, Vašoj tjelesnoj težini i količini faktora IX u krvi.
English: Catheter-related complications
Croatian: Komplikacije povezane s kateterima
English: The clinical relevance of antibodies to mouse protein, if these do indeed arise, is not known.
Croatian: Klinički značaj protutijela na mišje proteine, ako se ona doista pojave, nije poznat.
English: What Nonafact looks like and contents of the pack
Croatian: Kako Nonafact izgleda i sadržaj pakiranja
English: Your doctor will determine the dose of Nonafact you need and how frequently you should use it depending on the situation.
Croatian: Liječnik će odlučiti koju dozu lijeka Nonafact trebate i kako često ga trebate koristiti ovisno o situaciji.
English: The resulting solution is clear, colourless to light yellow and has a neutral pH.
Croatian: Dobivena otopina je prozirna, bezbojna do blago žuta i ima neutralni pH.
English: DD month YYYY
Croatian: DD mjesec GGGG
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Croatian: Stoga je u bolesnika koji su imali alergijske reakcije potrebno utvrditi prisutnost inhibitora.
English: The product should be used immediately.
Croatian: Lijek treba odmah primijeniti.
English: Paediatric population Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Croatian: Očekuje se da učestalost, vrsta i težina nuspojava u djece budu iste kao i u odraslih.
English: In addition, the powder will dissolve more readily if both vials are first allowed to reach room temperature (15°C - 25°C).
Croatian: Osim toga, prašak će se bolje otopiti ako se obje bočice najprije ostave da se zagriju na sobnu temperaturu (15 °C - 25 °C).
English: Inhibitors
Croatian: Inhibitori
English: Known allergic reaction to mouse protein.
Croatian: Poznata alergijska reakcija na mišje proteine.
English: Store in a refrigerator (at 2°C - 8°C ).
Croatian: Čuvati u hladnjaku (na 2 °C - 8 °C).
English: If you suffer from a liver or cardiac disease or if you have recently had surgery, there is an increased risk for coagulation complications.
Croatian: Ako imate jetrenu ili srčanu bolest ili ste nedavno operirani, postoji povećan rizik od komplikacija zgrušavanja.
English: This must be carried out in hospital or under the careful supervision of a doctor.
Croatian: To se obavezno mora provesti u bolnici pod strogim liječničkim nadzorom.
English: 20-40 Repeat infusion every 24 hours.
Croatian: 20 - 40 Ponavljati infuziju svaka 24 sata.
English: Nonafact should never be mixed with other medicinal products.
Croatian: Nonafact se nikada ne smije miješati s drugim lijekovima.
English: NL-1066 CX Amsterdam The Netherlands
Croatian: NL-1066 CX Amsterdam Nizozemska
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (at 2C - 8C).
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku (na 2 C - 8 C).
English: You should tell your doctor if you know that you have a risk of thrombosis or you have had thromboembolic complications in the past, if you suffer from liver disease, cardiovascular disease, or if a surgery is planned.
Croatian: Recite svom liječniku ako znate da ste izloženi riziku od tromboze ili ste imali tromboembolijskih komplikacija u prošlosti, ako imate jetrenu ili kardiovaskularnu bolest ili ako ćete uskoro biti operirani.
English: Bring the two vials to a temperature between 15°C and 25°C.
Croatian: Zagrijte obje bočice na temperaturu između 15 °C i 25 °C.
English: There are no known interactions between Nonafact and other medicinal products.
Croatian: Nisu poznate interakcije između lijeka Nonafact i drugih lijekova.
English: This also applies to newborn babies and patients with an increased risk of thrombosis or “DIC” (disseminated intravascular coagulation) a disease in which the blood coagulation system is disturbed.
Croatian: Navedeno se također odnosi na novorođenčad i bolesnike s povećanim rizikom za trombozu ili "DIK" (disiminiranu intravaskularnu koagulaciju), bolest u kojoj je poremećen sustav zgrušavanja krvi.
English: Your doctor will decide how much Nonafact you require.
Croatian: Vaš liječnik će odlučiti koliko lijeka Nonafact trebate.
English: You will be closely monitored for any possible side effect during this treatment.
Croatian: Tijekom tog liječenja bit ćete pažljivo praćeni zbog svih mogućih nuspojava.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.
Croatian: Za upute o rekonstituciji lijeka prije primjene vidjeti dio 6.
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Croatian: U literaturi postoje izvješća koja upućuju na korelaciju između pojave inhibitora faktora IX i alergijskih reakcija.
English: What Nonafact is and what it is used for What you need to know before you use Nonafact How to use Nonafact
Croatian: Što je Nonafact i za što se koristi Što morate znati prije nego počnete primjenjivati Nonafact Kako primjenjivati Nonafact
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Croatian: Liječenje je potrebno provoditi pod nadzorom liječnika s iskustvom u liječenju hemofilije.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Croatian: Dozu temeljenu na tjelesnoj težini možda će biti potrebno prilagoditi u slučaju bolesnika s premalom ili prekomjernom tjelesnom težinom.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V *.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also 4.4).
Croatian: Navedene reakcije su u nekim slučajevima napredovale do teške anafilaksije i pojavile su se u bliskoj vremenskoj povezanosti s razvojem inhibitora faktora IX (također vidjeti dio 4.4).
English: Disinfect the surface of the stoppers of both vials with a gauze soaked in 70 % alcohol.
Croatian: Dezinficirajte površinu čepa obje bočice tupferom natopljenim 70%-tnim alkoholom.
English: In the case of a severe allergic reaction (anaphylactic shock), immediately stop the administration of the product and contact your doctor immediately.
Croatian: U slučaju teške alergijske reakcije (anafilaktički šok), odmah prekinite primjenu lijeka i obratite se svom liječniku.
English: Do not use solutions that are cloudy or have deposits.
Croatian: Ne koristite otopine koje su zamućene ili imaju talog.
English: The administration of Nonafact can compensate for this deficiency.
Croatian: Primjena lijeka Nonafact može nadoknaditi taj nedostatak.
English: Your doctor will check your blood regularly for the presence of these antibodies, especially if you experienced a severe allergic reaction with the previous use of a factor IX product.
Croatian: Liječnik će redovito provjeravati Vašu krv na prisutnost ovih protutijela, osobito ako ste pri prethodnom primanju pripravaka faktora IX imali tešku alergijsku reakciju.
English: The powder should be dissolved in the supplied amount of water for injections.
Croatian: Prašak treba otopiti u pripremljenoj količini vode za injekcije.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: If you have previously experienced hypersensitivity in response to the administration of blood or a blood product, Nonafact should only be administered when absolutely necessary (in life-threatening situations).
Croatian: Ako ste ranije doživjeli preosjetljivost na primjenu krvi ili krvnih pripravaka, Nonafact se smije primijeniti samo kad je to apsolutno potrebno (u po život opasnim slučajevima).
English: If you are administered 1 International Unit (IU) per kilogram of body weight, the concentration of factor IX in your blood will increase by 1.1 % of normal activity.
Croatian: Ako primijenite 1 međunarodnu jedinicu (IU) po kilogramu tjelesne težine, koncentracija faktora IX u Vašoj krvi će porasti za 1,1% u odnosu na normalnu aktivnost.
English: Your body may develop antibodies (inhibitors) against factor IX, which will inactivate Nonafact.
Croatian: Vaše tijelo može razviti protutijela (inhibitore) protiv faktora IX koja će deaktivirati Nonafact.
English: Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated.
Croatian: Stoga se faktor IX tijekom trudnoće i dojenja treba primjenjivati samo ako je to jasno indicirano.
English: In pharmacodynamic studies in rabbits and guinea pigs, the thrombogenicity of Nonafact was shown to be minimal.
Croatian: U farmakodinamičkim ispitivanjima na kunićima i zamorcima pokazana je minimalna trombogenost lijeka Nonafact.
English: Remove the empty vial and the transfer needle.
Croatian: Uklonite praznu bočicu i iglu za prijenos.
English: After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Croatian: Nakon ponovljenog liječenja lijekovima s ljudskim koagulacijskim faktorom IX, kod bolesnika je potrebno pratiti razvoj neutralizirajućih protutijela (inhibitora), koje je potrebno kvantificirati u Bethesda jedinicama (BU) odgovarajućim biološkim testovima.
English: The safety and efficacy of Nonafact in previously untreated patients have not been established.
Croatian: Sigurnost i djelotvornost lijeka Nonafact kod prethodno neliječenih bolesnika nije ustanovljena.
English: From a microbiological point of view the product, once dissolved, should be used immediately, but no longer than 3 hours after reconstitution.
Croatian: S mikrobiološkog stajališta lijek se, nakon otapanja, treba odmah upotrijebiti, ali ne nakon više od 3 sata od pripreme otopine.
English: This also applies to unknown or emerging viruses or other pathogens.
Croatian: Ovo se također odnosi na nepoznate ili novonastale viruse i ostale patogene.
English: The use of high purity factor IX is rarely associated with such adverse reactions.
Croatian: Korištenje pripravaka visoke čistoće faktora IX je rijetko povezano s navedenim nuspojavama.
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OF THE MARKETING AUTHORISATION C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II. A. PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Particularly with major surgery, it is important that the concentrations of factor IX in your blood are checked carefully before and after the operation.
Croatian: Osobito u slučaju velikih operacija, važno je da se koncentracija faktora IX u Vašoj krvi temeljito provjeri prije i nakon operacije.
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Croatian: Najmanje 1 dan, sve dok se krvarenje na koje upućuje bol ne zaustavi ili ne dođe do cijeljenja.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Croatian: Potrebna količina i učestalost primjene uvijek trebaju biti određeni na temelju kliničke učinkovitosti u svakom pojedinom slučaju.
English: Other medicines and Nonafact
Croatian: Drugi lijekovi i Nonafact
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness
Croatian: Unutar svake kategorije učestalosti nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: From a microbiological point of view, the product should be used immediately after reconstitution.
Croatian: S mikrobiološkog stajališta, lijek se mora primijeniti odmah nakon rekonstitucije.
English: Your doctor will consider whether administration of Nonafact imposes a risk for coagulation complications.
Croatian: Vaš liječnik će razmotriti predstavlja li primjena lijeka Nonafact rizik za komplikacije zgrušavanja.
English: • A vial of Nonafact containing 500 IU or 1000 IU of factor IX
Croatian: • Bočicu lijeka Nonafact koja sadrži 500 IU ili 1000 IU faktora IX
English: The powder dissolves within 5 minutes to produce a clear, colourless to light-yellow solution.
Croatian: Prašak se otapa za 5 minuta i nastaje prozirna, bezbojna do blago žuta otopina.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Croatian: Postoji potencijalni rizik za pojavu tromboembolijskih događaja nakon primjene pripravaka faktora IX; uz veći rizik kod pripravaka niske čistoće.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Croatian: Osobito u slučaju velikih kirurških zahvata, neophodno je precizno praćenje nadomjesnog liječenja pomoću analiza zgrušavanja krvi (aktivnost faktora IX u plazmi).
English: Haemophilia B is a chronic disease, therefore lifelong treatment with a factor IX product may be necessary.
Croatian: Hemofilija B je kronična bolest, stoga može biti potrebno doživotno liječenje faktorom IX.
English: Immediately before administration, the solution should be inspected: the solution should be clear or slightly opalescent.
Croatian: Neposredno prije primjene potrebno je pregledati otopinu: otopina mora biti bistra ili blago opalescentna.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Preosjetljivost ili alergijske reakcije (koje uključuju angioedem, pečenje i žarenje na mjestu infuzije, zimicu, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju) rijetko su opažene i mogu u nekim slučajevima napredovati do teške anafilaksije (uključujući šok).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, the Netherlands 12.
Croatian: Sanquin, Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, Nizozemska
English: Powder:
Croatian: Prašak:
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Croatian: Aktivnost faktora IX u plazmi izražava se ili u postocima (u odnosu na normalnu ljudsku plazmu) ili u međunarodnim jedinicama (u odnosu na Međunarodni standard za faktor IX u plazmi).
English: Contraindications
Croatian: Kontraindikacije
English: 30-60 Every 24 hours, at least 1 day, until healing is achieved.
Croatian: 30 - 60 Svaka 24 sata, najmanje 1 dan, sve do cijeljenja rane.
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of human plasma.
Croatian: Jedna međunarodna jedinica (IU) aktivnosti faktora IX odgovara količini faktora IX u jednom ml ljudske plazme.
English: Life threatening bleeding
Croatian: Krvarenja opasna po život
English: Paediatric population There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Croatian: Pedijatrijska populacija Nema dovoljno podataka za preporuku primjene lijeka Nonafact u djece u dobi mlađoj od 6 godina.
English: It is important that the concentration of factor IX in your blood is checked regularly.
Croatian: Važno je da se koncentracija faktora IX u Vašoj krvi redovito kontrolira.
English: Sanquin Plasma Products B.V. Plesmanlaan 125
Croatian: Sanquin Plasma Products B.V.
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Croatian: One uključuju pažljivi odabir darivatelja krvi i plazme kako bi se osiguralo da se isključe osobe s rizikom za prijenos infekcije te testiranje svakog darivanja i sakupljene plazme na znakove virusa/infekcije.
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30 % to 60 % (IU/dl).
Croatian: Ponavljati infuziju svakih 8 - 24 sata sve do odgovarajućeg cijeljenja rane, nastaviti liječenje najmanje sljedećih 7 dana kako bi se aktivnost faktora IX održavala između 30% i 60% (IU/dl).
English: If you need therapy for repressing antibodies (inhibitors) this should be taken care of in a haemophilia treating centre.
Croatian: Ako trebate liječenje za suzbijanje protutijela (inhibitora), potrebno ga je provesti u centru za liječenje hemofilije.
English: Nonafact has no known effects on the ability to drive and to use machines.
Croatian: Nonafact nema poznatih učinaka na sposobnost upravljanja vozilima i rada sa strojevima.
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Croatian: Pojedini bolesnici mogu različito odgovarati na faktor IX, postizanjem različitih vrijednosti poluvijekova i povrata.
English: A deficiency of factor IX causes blood coagulation problems, which may lead to bleeding in joints, muscles or internal organs.
Croatian: Nedostatak faktora IX uzrokuje probleme sa zgrušavanjem krvi, što može prouzročiti krvarenje u zglobove, mišiće ili unutarnje organe.
English: Contents:
Croatian: Sadržaj:
English: C.
Croatian: B.
English: Factor IX is a normal constituent of human blood.
Croatian: Faktor zgrušavanja IX je normalni sastojak ljudske krvi.
English: The dose and duration of substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Croatian: Doza i trajanje nadomjesne terapije ovise o težini nedostatka faktora IX, mjestu i jačini krvarenja te kliničkom stanju bolesnika.
English: The potency (IU) is determined using the European Pharmacopoeia one stage clotting test..
Croatian: Potentnost (IU) je određena pomoću jednofaznog testa zgrušavanja krvi prema Europskoj farmakopeji.
English: Before administration, check that the solution is clear or slightly opalescent.
Croatian: Prije primjene, provjerite je li otopina bistra ili blago opalescentna.
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 1.1 % of normal activity.
Croatian: Izračun potrebne doze faktora IX temelji se na empirijskom saznanju da 1 međunarodna jedinica (IU) faktora IX po kg tjelesne težine povisuje aktivnost faktora IX u plazmi za 1,1% normalne aktivnosti.
English: Do not use Nonafact:
Croatian: Nemojte primjenjivati Nonafact:
English: If you have existing cardiovascular risk factors, substitution therapy with Factor IX may increase the cardiovascular risk.
Croatian: Ako imate postojeće kardiovaskularne čimbenike rizika, nadomjesna terapija faktorom IX može povećati kardiovaskularni rizik.
English: Because of the risk of allergic reactions with factor IX products, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Croatian: Uslijed rizika pojave alergijskih reakcija na lijekove s faktorom IX, početne primjene faktora IX potrebno je, prema prosudbi liječnika koji provodi liječenje, provoditi pod medicinskim nadzorom gdje je moguće pružiti odgovarajuću medicinsku skrb za alergijske reakcije.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Tablica u nastavku u skladu je s klasifikacijom organskih sustava prema MedDRA-i (klasifikacija organskih sustava i razina preporučenog pojma).
English: 1 vial of powder for solution for injection 1 vial water for injections 5 ml 1 vial water for injections 10 ml
Croatian: 1 bočica s praškom za otopinu za injekciju 1 bočica s 5 ml vode za injekcije 1 bočica s 10 ml vode za injekcije
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Croatian: Kod bolesnika s postojećim kardiovaskularnim čimbenicima rizika, nadomjesna terapija FIX-om može povećati kardiovaskularni rizik.
English: This also applies to any unknown or emerging viruses or other types of infections.
Croatian: Ovo se također odnosi na nepoznate ili novootkrivene viruse i ostale uzročnike infekcija.
English: Frequency of doses (hours)/ Duration of therapy (days)
Croatian: Učestalost doza (sati)/Trajanje terapije (dani)
English: Remove from the refrigerator and allow the two vials to reach room temperature (15°C - 25°C).
Croatian: Izvadite iz hladnjaka i ostavite obje bočice da se zagriju na sobnu temperaturu (15 °C - 25 °C).
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: C OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET