FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION KOGENATE Bayer 2000 IU powder for solution for injection Recombinant coagulation factor VIII (octocog alfa) Intravenous use.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA KOGENATE Bayer 2000 IU prašak za otopinu za injekciju rekombinantni koagulacijski faktor VIII (oktokog alfa) Primjena u venu.
English: KOGENATE Bayer powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) in the prefilled syringe and the vial adapter.
Croatian: Prašak KOGENATE Bayer smije se pripremati samo otapalom (5,0 ml vode za injekcije) priloženim u napunjenoj štrcaljki i pomoću nastavka za bočicu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/011
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/143/011
English: Each pack of KOGENATE Bayer 500 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 500 IU sadrži bočicu s uređajem za prijenos Bio-Set i napunjenu štrcaljku s odvojenim potisnim klipom, kao i set za venepunkciju (za ubrizgavanje u venu), dva tupfera natopljena alkoholom, dva suha tupfera i dva flastera.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/143/004
English: How much KOGENATE Bayer 2000 IU you should use and how often you should use it depends on many factors such as your weight, the severity of your haemophilia, where the bleed is and how serious it is, whether you have inhibitors and how high the inhibitor titre is and the factor VIII level that is needed.
Croatian: Količina i učestalost uzimanja lijeka KOGENATE Bayer 2000 IU ovise o brojnim čimbenicima kao što su tjelesna težina, stupanj hemofilije, mjesto i težina krvarenja, prisutnost inhibitora, visina titra inhibitora te potrebna razina faktora VIII.
English: NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 1000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Croatian: KOGENATE Bayer 1000 IU prašak i otapalo za otopinu za injekciju rekombinantni koagulacijski faktor VIII (oktokog alfa)
English: NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 2000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Croatian: KOGENATE Bayer 2000 IU prašak i otapalo za otopinu za injekciju rekombinantni koagulacijski faktor VIII (oktokog alfa)
English: Each pack of KOGENATE Bayer 3000 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 3000 IU sadrži bočicu s uređajem za prijenos Bio-Set i napunjenu štrcaljku s odvojenim potisnim klipom, kao i set za venepunkciju (za ubrizgavanje u venu), dva tupfera natopljena alkoholom, dva suha tupfera i dva flastera.
English: KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) in the prefilled syringe and the vial adapter.
Croatian: Prašak KOGENATE Bayer smije se pripremati samo otapalom (2,5 ml vode za injekcije) priloženim u napunjenoj štrcaljki i pomoću nastavka za bočicu.
English: Each pack of KOGENATE Bayer 250 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 250 IU sadrži bočicu i napunjenu štrcaljku s odvojenim potisnim klipom, kao i adapter za bočicu, set za venepunkciju (za ubrizgavanje u venu), dva tupfera natopljena alkoholom, dva suha tupfera i dva flastera.
English: Other medicines and KOGENATE Bayer 500 IU Interactions with other medicines are not known.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu zabilježene interakcije lijeka KOGENATE Bayer s drugim lijekovima.
English: Each pack of KOGENATE Bayer 1000 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 1000 IU sadrži bočicu s uređajem za prijenos Bio-Set i napunjenu štrcaljku s odvojenim potisnim klipom, kao i set za venepunkciju (za ubrizgavanje u venu), dva tupfera natopljena alkoholom, dva suha tupfera i dva flastera.
English: Each pack of KOGENATE Bayer 500 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 500 IU sadrži bočicu i napunjenu štrcaljku s odvojenim potisnim klipom, kao i adapter za bočicu, set za venepunkciju (za ubrizgavanje u venu), dva tupfera natopljena alkoholom, dva suha tupfera i dva flastera.
English: Medical devices for reconstitution and administration are provided with each package of KOGENATE Bayer 250 IU.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 250 IU sadrži medicinske proizvode za pripremu i primjenu.
English: KOGENATE Bayer 1000 IU contains the active substance human recombinant coagulation factor VIII (octocog alfa).
Croatian: Što je KOGENATE Bayer 1000 IU i za što se koristi KOGENATE Bayer 1000 IU kao djelatnu tvar sadrži ljudski rekombinantni koagulacijski faktor VIII (oktokog alfa).
English: Each pack of KOGENATE Bayer 3000 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 3000 IU sadrži bočicu i napunjenu štrcaljku s odvojenim potisnim klipom, kao i adapter za bočicu, set za venepunkciju (za ubrizgavanje u venu), dva tupfera natopljena alkoholom, dva suha tupfera i dva flastera.
English: Each pack of KOGENATE Bayer 2000 IU contains a vial with Bio-Set transfer device and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 2000 IU sadrži bočicu s uređajem za prijenos Bio-Set i napunjenu štrcaljku s odvojenim potisnim klipom, kao i set za venepunkciju (za ubrizgavanje u venu), dva tupfera natopljena alkoholom, dva suha tupfera i dva flastera.
English: Each pack of KOGENATE Bayer 1000 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 1000 IU sadrži bočicu i napunjenu štrcaljku s odvojenim potisnim klipom, kao i adapter za bočicu, set za venepunkciju (za ubrizgavanje u venu), dva tupfera natopljena alkoholom, dva suha tupfera i dva flastera.
English: 1 vial adapter
Croatian: Aktivirani faktor X
English: KOGENATE Bayer 2000 IU contains the active substance human recombinant coagulation factor VIII (octocog alfa).
Croatian: Što je KOGENATE Bayer 2000 IU i za što se koristi KOGENATE Bayer 2000 IU kao djelatnu tvar sadrži ljudski rekombinantni koagulacijski faktor VIII (oktokog alfa).
English: Each pack of KOGENATE Bayer 2000 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 2000 IU sadrži bočicu i napunjenu štrcaljku s odvojenim potisnim klipom, kao i adapter za bočicu, set za venepunkciju (za ubrizgavanje u venu), dva tupfera natopljena alkoholom, dva suha tupfera i dva flastera.
English: Medical devices for reconstitution and administration are provided with each package of KOGENATE Bayer 2000 IU.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 2000 IU sadrži medicinske proizvode za pripremu i primjenu.
English: Medical devices for reconstitution and administration are provided with each package of KOGENATE Bayer 1000 IU.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 1000 IU sadrži medicinske proizvode za pripremu i primjenu.
English: Medical devices for reconstitution and administration are provided with each package of KOGENATE Bayer 500 IU.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 500 IU sadrži medicinske proizvode za pripremu i primjenu.
English: Haemoglobin levels were maintained at around 11.4 g/dl in both groups.
Croatian: Razine hemoglobina održale su se na približno 11,4 g/dl u obje skupine.
English: Silapo received a marketing authorisation valid throughout the EU on 18 December 2007.
Croatian: Lijek Silapo dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 18. prosinca 2007.
English: Further information on Silapo can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/Silapo
Croatian: Više informacija o lijeku Silapo nalazi se na internetskim stranicama Agencije:ema.europa.eu/en/medicines/human/EPAR/Silapo
English: After that, the two groups switched to receiving the other medicine for a further 12 weeks.
Croatian: Nakon toga zamijenjeni su lijekovi te su obje skupine primale drugi lijek tijekom sljedećih 12 tjedana.
English: Why is Silapo authorised in the EU?
Croatian: Zašto je Silapo odobren u EU-u?
English: For these patients, the lowest dose that controls the symptoms well enough should be used.
Croatian: Za te bolesnike treba se koristiti najniža doza koja adekvatno kontrolira simptome.
English: This means that Silapo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: To znači da je Silapo vrlo sličan drugom biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
English: This summary was last updated in 02-2019.
Croatian: Sažetak je posljednji put ažuriran u 2. 2019.
English: What is Silapo and what is it used for?
Croatian: Što je Silapo i za što se primjenjuje?
English: What measures are being taken to ensure the safe and effective use of Silapo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Silapo?
English: The most common side effects with Silapo (which may affect more than 1 in 100 people) are headache and increased blood pressure.
Croatian: Najčešće nuspojave lijeka Silapo (mogu se javiti u više od 1 na 100 osoba) su glavobolja i povišeni krvni tlak.
English: The iron levels of all patients should be checked and iron supplements given if necessary.
Croatian: Potrebno je provjeriti razine željeza u svih bolesnika te davati dodatke željeza prema potrebi.
English: During the last 4 weeks of the study haemoglobin levels were around 11.6 g/dl, having risen from around 8.0 g/dl before treatment.
Croatian: Tijekom zadnja 4 tjedna ispitivanja, razine hemoglobina iznosile su približno 11,6 g/dl, što je porast u odnosu na otprilike 8,0 g/dl prije terapije.
English: For more information on biosimilar medicines, see here.
Croatian: Više informacija o biosličnim lijekovima potražiteovdje.
English: An overview of Silapo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Silapo i zašto je odobren u EU-u
English: Side effects reported with Silapo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Silapo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What are the risks associated with Silapo?
Croatian: Koji su rizici povezani s lijekom Silapo?
English: In these cases, epoetin zeta is used to increase red blood cell counts.
Croatian: U tim slučajevima epoetin zeta koristi se za povećanje broja crvenih krvnih stanica.
English: Epoetin zeta is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Croatian: Epoetin zeta također se koristi prije kirurškog zahvata kako bi se povećao broj crvenih krvnih stanica i ublažile posljedice gubitka krvi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silapo have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Silapo nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The injection under the skin may be given by the patient or a carer if they have been trained.
Croatian: Injekciju pod kožu mogu primjenjivati sami bolesnici ili pružatelji skrbi ako su prošli obuku.
English: Silapo can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Silapo is approved for.
Croatian: Silapo se izdaje samo na liječnički recept, a liječenje se mora započeti pod nadzorom liječnika s iskustvom u liječenju bolesnika sa stanjima za koje je Silapo odobren.
English: The reference medicine for Silapo is Eprex/Erypo, which contains epoetin alfa.
Croatian: Referentni lijek za Silapo je Eprex/Erypo, koji sadrži epoetin alfa.
English: As for all medicines, data on the use of Silapo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Silapo kontinuirano se prate.
English: Silapo is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.
Croatian: Silapo se primjenjuje kada su bolesnici izloženi niskom ili umjerenom riziku od razvoja akutne mijeloidne leukemije i imaju niske razine prirodnog hormona eritropoetina.
English: All of the patients in the second study had received treatment with Eprex/Erypo for at least 3 months before they were either switched to Silapo or remained on Eprex/Erypo for 12 weeks.
Croatian: Svi bolesnici u drugom ispitivanju primali su terapiju lijekom Eprex/Erypo barem tri mjeseca prije nego što su prešli na terapiju lijekom Silapo ili su ostali na terapiji lijekom Eprex/Erypo sljedećih 12 tjedana.
English: The company also presented the results of two studies showing that Silapo injected under the skin is as effective as other epoetin medicines: one study involved 261 cancer patients receiving chemotherapy, and the other compared Silapo with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.
Croatian: Tvrtka je također predstavila rezultate dvaju ispitivanja koja su utvrdila da je lijek Silapo injektiran pod kožu bio jednako učinkovit kao i drugi lijekovi s epoetinom: jedno je ispitivanje uključivalo 261 bolesnika s rakom na kemoterapiji, a u drugom je uspoređen lijek Silapo s lijekom Eprex/Erypo u 462 bolesnika s anemijom uzrokovanom problemima s bubrezima.
English: Silapo is available in pre-filled syringes and is injected either into a vein or under the skin, depending on the condition for which the patient is being treated.
Croatian: Silapo je dostupan u obliku napunjenih štrcaljki i daje se kao injekcija u venu ili pod kožu, ovisno o stanju za koje se bolesnika liječi.
English: Erythropoietin is produced by the kidneys.
Croatian: Eritropoetin se stvara u bubrezima.
English: Because Silapo is a biosimilar medicine, the studies on effectiveness and safety of epoetin carried out with Eprex/Erypo do not all need to be repeated for Silapo.
Croatian: Budući da je lijek Silapo biosličan lijek, ispitivanja učinkovitosti i sigurnosti epoetina provedena za lijek Eprex/Erypo nije potrebno ponavljati za lijek Silapo.
English: For more information about using Silapo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Silapo pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Silapo has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Silapo ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Eprex/Erypo te se u tijelu raspoređuje na isti način.
English: The dose, how often it is given and how long it is used for also depend on why Silapo is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working.
Croatian: Doza, učestalost injektiranja i trajanje primjene također ovise o razlogu primjene lijeka Silapo i tjelesnoj težini bolesnika te se prilagođavaju u skladu s djelovanjem lijeka.
English: For patients with kidney failure, myelodysplastic syndromes or who are receiving chemotherapy, haemoglobin levels should remain within the recommended range.
Croatian: U bolesnika sa zatajenjem bubrega, mijelodisplastičnim sindromima ili onih na kemoterapiji razine hemoglobina moraju ostati unutar preporučenog raspona.
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding well enough to natural erythropoietin.
Croatian: Kod bolesnika koji primaju kemoterapiju ili imaju problema s bubrezima anemiju može uzrokovati manjak eritropoetina ili kada tijelo adekvatno ne reagira na eritropoetin koji se prirodno nalazi u tijelu.
English: What benefits of Silapo have been shown in studies?
Croatian: Koje su koristi od lijeka Silapo utvrđene u ispitivanjima?
English: The active substance in Silapo, epoetin zeta, is a copy of a hormone called erythropoietin, and works in the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Croatian: Djelatna tvar lijeka Silapo, epoetin zeta, kopija je hormona naziva eritropoetin koja djeluje na isti način kao prirodni hormon za stimulaciju proizvodnje crvenih krvnih stanica iz leđne moždine.
English: All these data were considered sufficient to conclude that Silapo will behave in the same way as Eprex/Erypo in terms of effectiveness and safety in its authorised uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Silapo djelovati na isti način kao i lijek Eprex/Erypo pogledu učinkovitosti i sigurnosti primjene.
English: Silapo, injected into a vein, was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a procedure for removing waste products from the blood).
Croatian: Kada je injektiran u venu, Silapo je bio jednako učinkovit kao i Eprex/Erypo u normaliziranju i održavanju razina crvenih krvnih stanica u dva glavna ispitivanja koja su uključivala 922 bolesnika s anemijom povezanom s kroničnim zatajenjem bubrega koja je zahtijevala hemodijalizu (postupak za uklanjanje otpadnih tvari iz krvi).
English: It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;
Croatian: Primjenjuje se u bolesnika s normalnim koncentracijama željeza u krvi, koji bi mogli imati komplikacije ako prime transfuziju krvi, u slučaju da nemaju prilike donirati svoju vlastitu krv prije kirurškog zahvata, za koje se očekuje da će izgubiti 900 do 1 800 ml krvi; liječenje anemije u odraslih bolesnika s mijelodisplastičnim sindromima (stanjima kod kojih proizvodnja zdravih krvnih stanica nije ispravna).
English: Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Silapo outweighs the identified risk and it can be authorised.
Croatian: Stoga je stav Agencije da koristi od lijeka Silapo, kao i kod lijeka Eprex/Erypo, nadmašuju identificirani rizik te da lijek može biti odobren.
English: In addition, studies have shown that the effects of the medicine are equivalent to those of Eprex/Erypo in increasing and maintaining blood cell counts in patients with chronic kidney failure or undergoing chemotherapy.
Croatian: Nadalje, ispitivanima je utvrđeno da su učinci lijeka ekvivalentni učincima lijeka Eprex/Erypo u povećanju i zadržavanju broja krvnih stanica u bolesnika s kroničnim zatajenjem bubrega ili bolesnika koji primaju kemoterapiju.
English: Silapo contains the active substance epoetin zeta and is a ‘biosimilar' medicine.
Croatian: Silapo sadrži djelatnu tvar epoetin zeta te je „biosličan lijek”.
English: Laboratory studies comparing Silapo with Eprex/Erypo have shown that the active substance in Silapo is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima je lijek Silapo uspoređivan s referentnim lijekom Eprex/Erypo pokazala su da je djelatna tvar u lijeku Silapo vrlo slična onoj u lijeku Eprex/Erypo u pogledu strukture, čistoće i biološke aktivnosti.
English: Studies have also shown that giving Silapo produces similar levels of the active substance in the body to giving Eprex/Erypo.
Croatian: Ispitivanja su također pokazala da primjena lijeka Silapo dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka Eprex/Erypo.
English: How is Silapo used?
Croatian: Kako se Silapo primjenjuje?
English: The second study compared the effects of Silapo with those of Eprex/Erypo in maintaining red blood cell counts in 313 patients.
Croatian: U drugom ispitivanju uspoređeni su učinci lijeka Silapo s onima lijeka Eprex/Erypo u održavanju razina crvenih krvnih stanica u 313 bolesnika.
English: The first study compared the effects of Silapo with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks.
Croatian: U prvom ispitivanju uspoređeni su učinci lijeka Silapo s onima lijeka Eprex/Erypo u normaliziranju razina crvenih krvnih stanica u 609 bolesnika tijekom 24 mjeseca.
English: Other information about Silapo:
Croatian: Ostale informacije o lijeku Silapo
English: • patients about to have surgery, including major orthopaedic surgery, and who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Croatian: Silapo se ne smije primjenjivati u sljedećim skupinama bolesnika: bolesnika koji su razvili čistu aplaziju krvnih stanica (smanjenu proizvodnju crvenih krvnih stanica ili prestanak njihove proizvodnje) nakon terapije bilo kojim lijekom s epoetinom; bolesnika s hipertenzijom (visokim krvnim tlakom) koji se ne može kontrolirati; bolesnika koji ne mogu primati lijekove za sprečavanje krvnih ugrušaka; bolesnika koji će uskoro biti podvrgnuti kirurškom zahvatu, uključujući veće ortopedske kirurške zahvate, i imaju ozbiljne kardiovaskularne probleme (probleme sa srcem i krvnim žilama), uključujući i nedavni srčani ili moždani udar.
English: For the full list of side effects of Silapo, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Silapo potražite u uputi o lijeku.