natgillin/translations-raw huggingface dataset:
This medicine may not be suitable for the following patients.
Ovaj lijek može biti neprikladan za skupine bolesnika navedene u daljnjem tekstu.
One of the most frequent adverse reactions during treatment with epoetin theta is an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase.
Jedna od najčešćih nuspojava tijekom liječenja epoetinom theta je porast krvnog tlaka ili pogoršanje postojeće hipertenzije osobito tijekom početne faze liječenja.
Common in patients with chronic renal failure (may affect up to 1 in 10 people) - Blood clot in the arterio-venous fistula in patients on dialysis.
Često u bolesnika s kroničnim zatajenjem bubrega (mogu se javiti u do 1 na 10 osoba) - krvni ugrušak u arterijsko-venskoj fistuli u bolesnika na dijalizi.
Once hypertension has been controlled with more intensified therapy, epoetin theta therapy should be re-started at a reduced dose.
Nakon što se intenzivnijom terapijom uspostavi kontrola hipertenzije, ponovno treba započeti liječenje epoetinom theta smanjenom dozom.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of epoetin theta in pregnant women.
Nema podataka ili su podaci o primjeni epoetina theta u trudnica ograničeni (manje od 300 ishoda trudnoća).
≥ 1/100 to < 1/10;
≥ 1/100 do < 1/10;
In cancer patients receiving chemotherapy, after repeated subcutaneous administration of 20,000 IU epoetin theta once-weekly, the terminal half-life is 29 hours after the first dose and 28 hours in steady state.
Kod bolesnika s karcinomom na kemoterapiji, nakon ponovljene supkutane primjene epoetina theta od 20.000 IU jednom tjedno, terminalni poluvijek je 29 sati nakon prve doze i 28 sati u stanju dinamičke ravnoteže.
Symptoms of influenza-like illness such as fever, chills and asthenic conditions have been reported.
Zabilježeni su i simptomi nalik gripi poput groznice, zimice i astenije.
Misuse of epoetin theta by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
Zlouporaba epoetina theta u zdravih osoba može dovesti do izrazitog porasta hemoglobina i hematokrita.
Press the injection site with a piece of gauze bandage or a sterile gauze swab for several seconds.
Na mjesto primjene injekcije pritisnite komadić gaze ili sterilnog štapića s gazom i držite nekoliko sekundi.
Push the safety shield towards the needle (see picture 12).
Potisnite sigurnosni štitnik prema igli (vidjeti sliku 12).
During haemodialysis, patients treated with epoetin theta may require increased anticoagulation treatment to prevent clotting of the arterio-venous shunt.
Tijekom hemodijalize kod bolesnika liječenih epoetinom theta može biti potrebno pojačati antikoagulantnu terapiju kako bi se spriječilo zgrušavanje arterijsko-venskog šanta.
● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
The solution is clear and colourless.
Otopina je bistra i bezbojna.
Do not remove the needle cover from the syringe until you are ready to inject.
Ne skidajte zaštitni poklopac s igle na štrcaljki dok niste spremni za primjenu.
Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Metaanalize također konzistentno indiciraju na povećan relativni rizik od tromboembolijskih događaja u bolesnika s karcinomom koji primaju rekombinantni humani eritropoetin (vidjeti dio 4.4).
The terminal half-life is higher than after intravenous administration, with an average of 25 hours after single dosing and 34 hours in steady state after repeated dosing three times weekly, without leading to an accumulation of epoetin theta.
Terminalni poluvijek veći je nakon intravenske primjene, s prosjekom od 25 sati nakon jednostruke doze i 34 sata u stanju dinamičke ravnoteže nakon ponovljenih doza tri puta tjedno, bez dovođenja do akumulacije epoetina theta.
Subcutaneous administration: The weekly dose can be given as one injection per week or three times per week.
Supkutana primjena: Tjedna doza može se dati jednom injekcijom tjedno ili tri puta tjedno.
Treatment for anaemia is given to adult patients with chronic renal failure or to adult patients with non-myeloid cancer (cancer not originating in the bone marrow) who at the same time are receiving chemotherapy (medicines to treat cancer).
Liječenje anemije se primjenjuje u odraslih bolesnika s kroničnim zatajenjem bubrega ili u odraslih bolesnika s nemijeloičnom zloćudnom bolešću (rakom koji ne potječe iz koštane srži), koji istovremeno primaju kemoterapiju (lijekove za liječenje raka).
If you stop using Biopoin
Ako prestanete primjenjivati Biopoin
Frequency groupings are defined according to the following convention:
Njihova je učestalost definirana kako slijedi: Vrlo često:
Biopoin contains sodium
Biopoin sadrži natrij
Due to limited experience, the efficacy and safety of epoetin theta could not be assessed in patients with impaired liver function or homozygous sickle cell anaemia.
Posebne populacije Zbog ograničenog iskustva, djelotvornost i sigurnost epoetina theta ne mogu se procijeniti u bolesnika s oštećenom jetrenom funkcijom ili homozigotnom anemijom srpastih stanica.
You will need to give yourself the injection into the tissue just under the skin.
Injekciju ćete si morati dati u tkivo pod kožom.
The pharmacokinetics of epoetin theta have been examined in healthy volunteers, in patients with chronic renal failure and in cancer patients receiving chemotherapy.
Farmakokinetička svojstva epoetina theta ispitana su u zdravih dobrovoljaca, u bolesnika s kroničnim zatajenjem bubrega i u bolesnika s karcinomom na kemoterapiji.
The angle between the syringe and skin should not be too narrow (at least 45°, see pictures 9 and 10).
Kut između štrcaljke i kože ne smije biti preuzak (najmanje 45°, vidjeti slike 9 i 10).
Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched (see picture 11).
Polagano i ravnomjerno ubrizgavajte otopinu u tkivo, držeći stalno nabor kože (vidjeti sliku 11).
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8,167 patients).
Metaanaliza podataka ukupnog preživljavanja dala je procjenu točke omjera rizika od 1,08 u korist kontrolne skupine (interval pouzdanosti od 95%: 0,99, 1,18; 42 ispitivanja i 8167 bolesnika).
Fertility No data are available.
Plodnost Nema dostupnih podataka.
It is recommended that haemoglobin measurement, a complete blood count and platelet count be performed regularly.
Preporučuje se redovito mjerenje hemoglobina, kompletne krvne slike i trombocita.
Patients should be monitored closely to ensure that the lowest approved effective dose of epoetin theta is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dl (7.45 mmol/l).
Bolesnike treba pažljivo pratiti kako bi se osigurala primjena najniže odobrene učinkovite doze epoetina theta kojom se istovremeno osigurava adekvatna kontrola simptoma anemije i održavanje koncentracije hemoglobina ispod ili na 12 g/dl (7,45 mmol/l).
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Ta su ispitivanja pokazala dosljedna, neobjašnjiva, statistički značajna povećanja smrtnosti kod bolesnika koji imaju anemiju povezanu s različitim čestim karcinomima i koji su primali rekombinantni humani eritropoetin u usporedbi s kontrolnim skupinama.
If this blood parameter becomes too high, heart or vascular problems might occur, increasing the risk of death.
Ako je vrijednost hemoglobina previsoka, mogu nastati srčani ili krvožilni problemi, čime se povećava rizik od smrtnog ishoda.
Biopoin is used for the treatment of anaemia accompanied by symptoms (for example fatigue, weakness and shortness of breath).
Biopoin se koristi u liječenju slabokrvnosti (anemije) praćene simptomima (na primjer, umorom,
In the case of overdose, polycythaemia can occur.
U slučaju predoziranja može se dogoditi policitemija.
Even at very high blood levels, no symptoms of poisoning have been observed.
Simptomi otrovanja nisu primijećeni čak ni pri vrlo visokim koncentracijama u krvi.
If you forget to use Biopoin
Ako ste zaboravili primjeniti Biopoin
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Simptomi i posljedice anemije mogu varirati s obzirom na dob, spol i sveukupnu težinu bolesti; liječnik treba nužno procijeniti klinički tijek i stanje svakog pojedinog bolesnika.
If your blood pressure rises, your doctor may give you medicines to reduce your blood pressure.
U slučaju porasta krvnog tlaka, liječnik će Vam dati lijekove kojima ćete ga sniziti.
You may remove Biopoin from the refrigerator and store it not above 25 °C for a single period of up to 7 days without exceeding the expiry date.
Biopoin možete izvaditi iz hladnjaka i čuvati ga na temperaturi ne iznad 25 °C u jednokratnom razdoblju od najdulje 7 dana, ukoliko nije istekao rok valjanosti lijeka.
- Put used syringes into the puncture-proof container and keep this container out of the sight and reach of children.
- Upotrijebljene igle stavite u neprobojni spremnik i čuvajte taj spremnik izvan pogleda i dosega djece.
If you have any problems, please ask your doctor or nurse for help and advice.
Ako imate bilo kakvih problema, molimo pitajte za pomoć i savjet svog liječnika ili medicinsku sestru.
These may be signs of severely elevated blood pressure (common in patients with chronic renal failure, may affect up to 1 in 10 people), even if your blood pressure is usually normal or low.
To mogu biti znakovi značajno povišenog krvnog tlaka (često u bolesnika s kroničnim zatajenjem bubrega, može se javiti u do 1 na 10 osoba), čak i ako inače imate normalan ili nizak krvni tlak.
Treatment with epoetin theta should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.07 mmol/l).
Liječenje epoetinom theta treba privremeno prekinuti ako su razine hemoglobina više od 13 g/dl (8,07 mmol/l).
In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
U tih bolesnika manjak eritropoetina i smanjen odgovor eritroidnih progenitornih stanica na endogeni eritropoetin oboje značajno povećavaju vjerojatnost pojave anemije.
If the frequency of administration is changed, haemoglobin level should be monitored closely and dose adjustments may be necessary.
Ako se promijeni učestalost primjene, razine hemoglobina treba pažljivo pratiti i može biti nužno prilagoditi dozu.
Patients were randomised to continue their current treatment or to be converted to epoetin theta (same dose as epoetin beta) in order to maintain their haemoglobin levels.
Bolesnici su randomizirani u skupine koje su ili nastavile primati postojeću terapiju ili počele primati epoetin theta (u istoj dozi kao i epoetin beta) kako bi se održale njihove vrijednosti hemoglobina.
Patients on epoetin theta therapy can experience an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase.
Kod bolesnika na terapiji epoetinom theta može doći do porasta krvnog tlaka ili pogoršanja postojeće hipertenzije, i to osobito tijekom početne faze liječenja.
A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing.
Paradoksalan pad hemoglobina i razvoj teške anemije povezane s niskim brojem retikulocita zahtijevaju promptni prekid terapije epoetinom i pretragu na antieritropoetinska antitijela.
These may be signs of severely elevated blood pressure, even if your blood pressure is usually normal or low.
To mogu biti znakovi značajno povišenog krvnog tlaka koji zahtijeva neodgodivo liječenje, čak i ako inače imate normalan ili nizak krvni tlak.
An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06; 35 trials and 6,769 patients) was observed in patients treated with recombinant human erythropoietin.
interval pouzdanosti 95%: 1,35, 2,06; 35 ispitivanja i 6769 bolesnika) zabilježen je u bolesnika liječenih rekombinantnim humanim eritropoetinom.
In both studies, treatment with epoetin theta resulted in a significant haemoglobin response (p < 0.001), defined as an increase in haemoglobin of ≥ 2 g/dl without transfusion, and a significant reduction in transfusion requirements (p < 0.05) in comparison to placebo.
liječenje epoetinom theta dovelo je do značajnog hemoglobinskog odgovora (p < 0,001) koji se definira kao porast hemoglobina od ≥ 2 g/dl bez transfuzije te do značajnog smanjenja potreba za transfuzijom (p < 0,05) u odnosu na skupinu koja je primala placebo.
Discontinuation of treatment with epoetin theta should be taken into account.
Treba uzeti u obzir prekid liječenja epoetinom theta.
Put the needle fully into the skin as shown by your doctor or nurse.
Ubodite iglu u kožu kao što Vam je pokazao Vaš liječnik ili medicinska sestra.
PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia.
Izolirana aplazija crvene krvne loze stanje je u kojem je tijelo prekinulo ili smanjilo stvaranje crvenih krvnih stanica, što uzrokuje tešku anemiju.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
U ispitivanju otvorenog tipa nije bilo razlike u ukupnom preživljavanju između bolesnika liječenih rekombinantnim humanim eritropoetinom i kontrolne skupine.
In addition, a reduction of the administered dose of epoetin theta needs to be considered.
Dodatno, treba uzeti u obzir smanjenje doze epoetina theta.
This medicine is given as an injection using a pre-filled syringe.
Ovaj se lijek daje injekcijom, uporabom napunjene štrcaljke.
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is erythropoietin deficiency.
Stvaranje endogenog eritropoetina smanjeno je kod bolesnika s kroničnim zatajenjem bubrega, pa je primarni uzrok njihove anemije manjak eritropoetina.
In patients with a poor haemoglobin response to epoetin theta, alternative explanations for the poor response should be considered (see sections 4.4 and 5.1).
U bolesnika sa slabim hemoglobinskim odgovorom na epoetin theta potrebno je razmotriti druga moguća objašnjenja slabog odgovora (vidjeti dijelove 4.4 i 5.1).
The maximum dose should not exceed 60,000 IU per week.
Najviša doza ne smije prijeći 60 000 IU tjedno.
Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched.
Polagano i ravnomjerno ubrizgavajte otopinu u tkivo, držeći stalno nabor kože.
Where your injection should be given
Gdje treba primijeniti injekciju
If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in picture 7).
Ako Vam netko drugi daje injekciju, može to učiniti i u stražnji i postranični dio nadlaktice (vidjeti siva područja na slici 7).
How to prepare for your injection
Kako pripremiti injekciju
Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 8).
Dezinficirajte mjesto primjene injekcije na koži uporabom maramice natopljene alkoholom te uhvatite nabor kože između palca i kažiprsta, bez stiskanja (vidjeti sliku 8).
Symptomatic anaemia associated chronic renal failure Data from correction phase studies in 284 chronic renal failure patients show that the haemoglobin response rates (defined as haemoglobin levels above 11 g/dl at two consecutive measurements) in the epoetin theta group (88.4% and 89.4% in studies in patients on dialysis and not yet undergoing dialysis, respectively) were comparable to epoetin beta (86.2% and 81.0%, respectively).
Podaci dobiveni iz ispitivanja u fazi korekcije, u kojima su sudjelovala 284 bolesnika s kroničnim zatajenjem bubrega, pokazuju da su stope hemoglobinskog odgovora (definirane kao razine hemoglobina više od 11 g/dl nakon dva uzastopna mjerenja) u skupini koja je primala epoetin theta (88,4% u bolesnika na dijalizi te 89,4% u bolesnika koji još nisu bili na dijalizi) usporedive s onima u bolesnika koji su primali epoetina beta (86,2%, odnosno 81,0%).
Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 7).
Dezinficirajte mjesto primjene injekcije na koži uporabom maramice natopljene alkoholom te uhvatite nabor kože između palca i kažiprsta, bez stiskanja (vidjeti sliku 7).
Allergic reactions such as skin rash, raised areas of the skin that itch and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported (not known, frequency cannot be estimated from the available data).
- Alergijske reakcije: Zabilježene su alergijske reakcije poput kožnog osipa, naticanja kože koja svrbi i teških alergijskih reakcija praćenih slabošću, padom krvnog tlaka, otežanim disanjem i naticanjem lica (nepoznato, učestalost se ne može procijeniti iz dostupnih podataka).
The angle between the syringe and skin should not be too narrow (at least 45°, see picture 8).
Kut između štrcaljke i kože ne smije biti preuzak (najmanje 45°, vidjeti sliku 8).
If you develop a serious rash or another of these skin symptoms, stop using Biopoin and contact your doctor or seek medical attention immediately.
U slučaju nastanka ozbiljnog osipa ili drugih kožnih simptoma, prestanite primjenjivati lijek Biopoin i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four week period should be avoided.
Treba izbjegavati porast hemoglobina veći od 2 g/dl (1,24 mmol/l) tijekom razdoblja od četiri tjedna.
Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
Hipertenzivna kriza sa simptomima nalik encefalopatiji (npr. glavobolje, zbunjenost, poremećaj govora, nestabilni hod) i povezanim komplikacijama (konvulzije, moždani udar) može se također javiti i kod bolesnika s inače niskim ili normalnim krvnim tlakom (vidjeti dio 4.4).
- The active substance is epoetin theta.
- Djelatna tvar je epoetin theta.
Subcutaneous use is preferable in patients who are not undergoing haemodialysis, in order to avoid puncturing peripheral veins.
Supkutana primjena preporučuje se kod bolesnika koji nisu na hemodijalizi da se izbjegne punkcija perifernih vena.
The recommended initial dose is 20,000 IU, independent of bodyweight, given once-weekly.
Preporučena početna doza je 20 000 IU, neovisno o tjelesnoj težini, jednom tjedno.
≥ 1/10,000 to < 1/1,000;
≥ 1/10 000 do < 1/1000;
Shunt thrombosis may occur, especially in patients who have a tendency to hypotension or whose arterio-venous fistulae exhibit complications (e.g. stenoses, aneurisms) (see section 4.4).
Može se javiti tromboza šanta i to posebno u bolesnika sa sklonošću hipotenziji ili u onih s izraženim komplikacijama arterijsko-venskih fistula (npr. stenoze, aneurizme) (vidjeti dio 4.4).
What Biopoin is and what it is used for What Biopoin is
Što je Biopoin i za što se koristi Što je Biopoin
If the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l) a doubling of the weekly dose to 40,000 IU should be considered.
Ako se vrijednosti hemoglobina nisu povećale za najmanje 1 g/dl (0,62 mmol/l), treba razmotriti udvostručenje tjedne doze na 40 000 IU.
Symptomatic anaemia associated with chronic renal failure The use of epoetin theta in nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible accelerated progression of renal failure cannot be ruled out with certainty.
Uporabu epoetina theta kod nefrosklerotičnih bolesnika koji još nisu na dijalizi treba definirati individualno, jer se ne može sa sigurnošću isključiti moguća ubrzana progresija zatajenja bubrega.
≥ 1/1,000 to < 1/100;
≥ 1/1000 do < 1/100;
The pre-filled syringes are for single use only.
Napunjene štrcaljke namijenjene su samo za jednokratnu primjenu.
The solution can be administered subcutaneously or intravenously.
Način primjene Otopina se može primijeniti supkutano ili intravenski.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Zbog razlika kod samih bolesnika, individualne vrijednosti hemoglobina kod bolesnika mogu povremeno biti i više i niže od željenih koncentracija.
Patients who do not have to undergo dialysis are usally given the injections under the skin.
Bolesnici koji nisu na dijalizi obično primaju injekcije potkožno.
If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in picture 6).
Ako Vam netko drugi daje injekciju, može to učiniti i u stražnji i postranični dio nadlaktice (vidjeti siva područja na slici 6).
In patients with chronic renal failure undergoing haemodialysis, the elimination half-life of epoetin theta is 6 hours after single dosing and 4 hours in steady state after repeated intravenous administration of 40 IU/kg body weight epoetin theta three times weekly.
Intravenska primjena Kod bolesnika s kroničnim zatajenjem bubrega koji su na hemodijalizi, poluvrijeme eliminacije epoetina theta je 6 sati nakon jednokratne doze i 4 sata u stanju dinamičke ravnoteže nakon ponovljene intravenske primjene epoetina theta od 40 IU/kg tjelesne težine, tri puta tjedno.
If PRCA is diagnosed, therapy with epoetin theta must be discontinued and patients should not be switched to another recombinant epoetin (see section 4.4).
Ako se dijagnosticira izolirana aplazija crvene krvne loze, terapija epoetinom theta mora se prekinuti, a bolesnici se ne smiju prebaciti na terapiju nekim drugim rekombinantnim epoetinom (vidjeti dio 4.4)
If epoetin theta is substituted for another epoetin, haemoglobin level should be monitored closely and the same route of administration should be used.
Ako se epoetin theta primjenjuje kao zamjena za neki drugi epoetin, razine hemoglobina treba pažljivo pratiti i lijek treba primjenjivati na isti način.
Some of the information required for using the pre-filled syringe can be found at the end of this package leaflet (see section “7.
Određene informacije potrebne za uporabu napunjene štrcaljke nalaze se na kraju ove upute o lijeku (vidjeti dio „Informacije za samoprimjenu injekcije“).
If epoetin theta is substituted for another epoetin, the same route of administration should be used.
Ako se epoetin theta primjenjuje kao zamjena za neki drugi epoetin, treba ga primjenjivati na isti način.
Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i napunjenoj štrcaljki iza“Rok valjanosti” ili EXP.
Biopoin 10,000 IU/1 ml, Biopoin 20,000 IU/1 ml and Biopoin 30,000 IU/1 ml: Each pre-filled syringe contains 1 ml of solution.
Biopoin 10 000 IU/1 ml, Biopoin 20 000 IU/1 ml i Biopoin 30 000 IU/1 ml: svaka napunjena štrcaljka sadrži 1 ml otopine.