FrancophonIA/ELRC3.0 huggingface dataset:
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Binocrit, treatment with Binocrit must not be restarted in this patient at any time.
Slovenian: Če je pri bolniku zaradi uporabe zdravila Binocrit prišlo do hude kožne reakcije, kot sta SJS ali TEN, zdravljenja z zdravilom Binocrit ni dovoljeno ponovno začeti.
English: • Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Binocrit treatment.
Slovenian: • Vaš zdravnik bo naročil krvne preiskave in po potrebi prilagodil odmerek, odvisno od odziva vaše anemije na zdravljenje z zdravilom Binocrit.
English: In patients with a poor haemoglobin response to Binocrit, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
Slovenian: Pri bolnikih s slabim odzivom hemoglobina na zdravilo Binocrit je treba iskati druge razlage za slab odziv (glejte poglavji 4.4 in 5.1).
English: Your Binocrit dose and frequency of administration may be further adjusted to maintain your response to treatment.
Slovenian: Po potrebi vam lahko odmerek zdravila Binocrit in pogostnost uporabe nadalje prilagaja, da se ohrani vaš odziv na zdravljenje.
English: Patients should be monitored closely to ensure that the lowest approved effective dose of Binocrit is used to provide adequate control of anaemia and of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dL (7.5 mmol/L).
Slovenian: Bolnike je treba skrbno spremljati, da se zagotovi uporaba najmanjšega odobrenega učinkovitega odmerka zdravila Binocrit za doseganje ustreznega nadzora anemije in simptomov anemije ob hkratnem ohranjanju koncentracije hemoglobina pod ali pri 12 g/dl (7,5 mmol/l).
English: 1 Common in dialysis 2 Includes arterial and venous, fatal and non fatal events, such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, arterial thrombosis (including myocardial infarction), cerebrovascular accidents (including cerebral infarction and cerebral haemorrhage) transient ischaemic attacks, and shunt thrombosis (including dialysis equipment) and thrombosis within arteriovenous shunt aneurisms 3 Addressed in the subsection below and/or in section 4.4
Slovenian: 1 Pogosto pri dializi 2 Vključuje arterijske in venske dogodke, s smrtnim izidom in brez njega, kot so globoka venska tromboza, pljučna embolija, tromboza mrežnice, arterijska tromboza (vključno z miokardnim infarktom), cerebrovaskularne dogodke (vključno s cerebralnim infarktom in cerebralno krvavitvijo), prehodne ishemične napade in trombozo šanta (vključno z dializno opremo) in trombozo v arteriovenskih anevrizmah šanta 3 Opisano v spodnjem podpoglavju in/ali v poglavju 4.4
English: These may affect more than 1 in 10 people.
Slovenian: Pojavijo se lahko pri več kot 1 od 10 bolnikov
English: Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dL or 6.2 to 8.1 mmol/L) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1,800 mL).
Slovenian: Uporabo je treba omejiti na bolnike z zmerno anemijo (npr. razpon koncentracije hemoglobina od 10 do 13 g/dl ali od 6,2 do 8,1 mmol/l), ki jim program avtolognega darovanja krvi ni na voljo in pri katerih se pričakuje zmerna izguba krvi (od 900 do
English: After single doses (20,000 to 160,000 IU subcutaneously) of epoetin alfa, a dose-dependent response was observed for the pharmacodynamic markers investigated including: reticulocytes, RBCs, and haemoglobin.
Slovenian: Po enkratnem odmerjanju (20.000 do 160.000 i.e. subkutano) epoetina alfa so opazili od odmerka odvisen odziv preučevanih farmakodinamičnih markerjev, vključno z retikulociti, RKC in hemoglobinom.
English: Iron supplements and other blood stimulants may increase the effectiveness of Binocrit.
Slovenian: Dodatki železa in druga sredstva za spodbujanje tvorbe krvi lahko povečajo učinkovitost zdravila
English: You may still be able to use Binocrit, but discuss it with your doctor first.
Slovenian: Morda boste kljub temu lahko uporabljali zdravilo Binocrit, vendar se najprej posvetujte s svojm zdravnikom.
English: Caution should be exercised with escalation of Binocrit doses in patients with chronic renal failure.
Slovenian: Previdnost je potrebna pri stopnjevanju odmerkov zdravila Binocrit pri bolnikih s kronično ledvično odpovedjo.
English: These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction.
Slovenian: Ti vključujejo venske in arterijske tromboze in embolizem (vključno z nekaj smrtnimi izidi), kot so globoka venska tromboza, pljučna embolija, tromboza mrežnice in miokardni infarkt.
English: Binocrit is a biosimilar medicinal product.
Slovenian: Zdravilo Binocrit je podobno biološko zdravilo.
English: Binocrit may be given by injection:
Slovenian: Zdravilo Binocrit se lahko daje z injiciranjem:
English: The recommended dose is Binocrit 600 IU/kg, administered subcutaneously weekly for three weeks (days -21, -14 and -7) prior to surgery and on the day of surgery (day 0).
Slovenian: Priporočeni odmerek zdravila Binocrit je 600 i.e./kg, ki se daje subkutano tedensko v obdobju treh tednov (na 21., 14. in 7. dan) pred kirurškim posegom in na dan kirurškega posega (dan 0).
English: Binocrit is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Slovenian: Zdravilo Binocrit je eno od zdravil iz skupine, ki spodbuja nastajanje rdečih krvnih celic na enak način kot humana beljakovina eritropoetin.
English: Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dL [6.2 to 8.1 mmol/L], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Slovenian: Zdravilo Binocrit smemo uporabiti samo pri bolnikih z zmerno anemijo (razpon koncentracije hemoglobina [Hb] od 10 do 13 g/dl [6,2 do 8,1 mmol/l] brez pomanjkanja železa), če postopki za ohranjanje krvi niso na voljo ali ne zadostujejo, kadar je za večji elektivni kirurški poseg potrebna velika količina krvi (4 ali več enot krvi za ženske ali 5 ali več enot za moške).
English: The mean volume of distribution was 49.3 mL/kg after intravenous doses of 50 and 100 IU/kg in healthy subjects.
Slovenian: Povprečni volumen porazdelitve je bil pri zdravih osebah 49,3 ml/kg po intravenskih odmerkih 50 in 100 i.e./kg.
English: If you are taking a medicine called cyclosporin (used e.g. after kidney transplants), your doctor may order blood tests to check the level of cyclosporin while you are taking Binocrit.
Slovenian: Če med zdravljenjem z zdravilom Binocrit jemljete zdravilo, imenovano ciklosporin (uporablja se npr. po presaditvi ledvic), lahko zdravnik naroči preiskave krvi, da preveri raven ciklosporina,
English: If you are given a product in this group other than Binocrit during your treatment, speak to your doctor or pharmacist before using it.
Slovenian: Če med zdravljenjem dobite drugo zdravilo iz te skupine, kot zdravilo Binocrit, se pred uporabo posvetujte s svojim zdravnikom ali farmacevtom.
English: When treatment starts, Binocrit is usually injected by a medical professional or a nurse.
Slovenian: Na začetku zdravljenja vam bo zdravilo Binocrit običajno injiciral zdravnišk ali medicinsko osebje.
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: • Binocrit is given by injection under the skin.
Slovenian: • Zdravilo Binocrit se daje v obliki injekcije pod kožo.
English: This section contains information on how to give yourself an injection of Binocrit.
Slovenian: To poglavje vsebuje navodila za to, kako morate sami sebi dajati injekcije zdravila Binocrit.
English: Where intravenous access is not readily available (patients not yet undergoing dialysis and peritoneal dialysis patients) Binocrit may be administered as a subcutaneous injection.
Slovenian: Kjer intravenski dostop ni takoj na razpolago (bolniki, ki se še ne zdravijo z dializo, in bolniki na peritonealni dializi), se zdravilo Binocrit lahko daje v obliki subkutane injekcije.
English: Binocrit is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.
Slovenian: Zdravilo Binocrit je indicirano za zdravljenje odraslih, pri katerih s kemoterapijo zdravimo solidne tumorje, maligni limfom ali multipli mielom, in pri tveganju za transfuzijo, ki ga ocenimo glede na bolnikovo splošno zdravstveno stanje (npr. kardiovaskularni status, prisotnost anemije že na začetku zdravljenja s kemoterapijo) za zdravljenje anemije in zmanjšanje potrebe po transfuziji.
English: • Before use, leave the Binocrit syringe to stand until it reaches room temperature.
Slovenian: • Pred uporabo počakajte, da zdravilo Binocrit doseže sobno temperaturo.
English: The recommended starting dose is Binocrit 450 IU/kg (maximum total dose is 40,000 IU) administered subcutaneously once every week, with not less than 5 days between doses.
Slovenian: Priporočeni začetni odmerek zdravila Binocrit je 450 i.e./kg (največji skupni odmerek je 40.000 i.e.), ki se daje subkutano enkrat na teden, pri čemer med odmerkoma ne sme miniti manj kot 5 dni.
English: If you develop a serious rash or another of these skin symptoms, stop taking Binocrit and contact your doctor or seek medical attention immediately.
Slovenian: Če se je pri vas pojavil hud izpuščaj ali kateri od teh kožnih simptomov, prenehajte z jemanjem zdravila Binocrit in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: • You may be given iron supplements before and during Binocrit treatment to make it more effective.
Slovenian: • Morda boste pred zdravljenjem z zdravilom Binocrit in po njem dobivali nadomestke železa, da bo zdravljenje bolj učinkovito.
English: If Binocrit is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Slovenian: Če se zdravilo Binocrit injicira pod kožo (subkutano), se z eno injekcijo navadno ne injicira količina,
English: Binocrit is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.
Slovenian: Zdravilo Binocrit je indicirano pred večjimi elektivnimi ortopedskimi kirurškimi posegi pri odraslih brez pomanjkanja železa, pri katerih obstaja veliko tveganje za zaplete pri transfuziji, za zmanjšanje izpostavljenosti alogenim transfuzijam krvi.
English: Moreover, in patients with a baseline haemoglobin of > 13 g/dL (> 8.1 mmol/L), the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/vascular events cannot be excluded.
Slovenian: Pri bolnikih z izhodiščno koncentracijo hemoglobina > 13 g/dl (> 8,1 mmol/l) ni mogoče izključiti možnosti, da je zdravljenje z epoetinom alfa lahko povezano z zvečanim tveganjem za pooperativne trombotične žilne dogodke.
English: Binocrit is used in moderately anaemic adults who donate some of their blood before surgery, so that it can be given back to them during or after the operation.
Slovenian: Zdravilo Binocrit se uporablja za zdravljenje zmerno anemičnih odraslih, ki pred kirurškim posegom darujejo nekaj svoje krvi, da jo lahko med kirurškim posegom ali po njem dobijo nazaj.
English: Binocrit can reduce the need for a blood transfusion in these patients.
Slovenian: Zdravilo Binocrit lahko pri teh bolnikih zmanjša potrebo po transfuziji krvi.
English: • You may take Binocrit out of the refrigerator and keep it at room temperature (up to 25°C) for no longer than 3 days.
Slovenian: • Zdravilo Binocrit lahko vzamete iz hladilnika in ga hranite pri sobni temperaturi (ne višji od
English: Your doctor will decide how Binocrit will be injected.
Slovenian: Vaš zdravnik se bo odločil, kako bo injicirano zdravilo Binocrit.
English: Before use, leave the Binocrit syringe to stand until it reaches room temperature.
Slovenian: Pred uporabo počakajte, da zdravilo Binocrit doseže sobno temperaturo.
English: Binocrit is not approved in the management of anaemia associated with hepatitis C.
Slovenian: Zdravilo Binocrit ni odobreno za obravnavanje anemije, povezane s hepatitisom C.
English: Binocrit is used to treat anaemia in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma (bone marrow cancer) who may have a need for a blood transfusion.
Slovenian: Zdravilo Binocrit se uporablja za zdravljenje anemije pri odraslih, če prejemate kemoterapijo za solidne tumorje, maligni limfom ali multipli mielom (rak kostnega mozga), ki morda potrebujejo transfuzijo krvi.
English: Binocrit is used in moderately anaemic adults about to have major orthopaedic surgery (for example hip or knee replacement operations), to reduce the potential need for blood transfusions.
Slovenian: Zdravilo Binocrit se uporablja pri zmerno anemičnih odraslih, naročenih na večji ortopedski kirurški poseg (na primer menjava kolka ali kolena), da se zmanjša morebitna potreba po transfuziji krvi.
English: Binocrit is used to treat symptomatic anaemia caused by kidney disease:
Slovenian: Zdravilo Binocrit se uporablja za zdravljenje simptomatske anemije, ki jo povzroči bolezen ledvic:
English: Patients should be monitored closely to ensure that the lowest approved dose of Binocrit is used to provide adequate control of anaemia and of the symptoms of anaemia.
Slovenian: Bolnike je treba skrbno spremljati, da se zagotovi uporaba najmanjšega odobrenega odmerka zdravila Binocrit za doseganje ustreznega nadzora anemije in njenih simptomov.
English: Binocrit is prescribed to stimulate your bone marrow to produce more red blood cells.
Slovenian: Zdravilo Binocrit se predpisuje za spodbujanje kostnega mozga k tvorbi rdečih krvnih celic.
English: How to use Binocrit
Slovenian: Kako uporabljati zdravilo Binocrit
English: From pretreatment to presurgery, the mean increase in haemoglobin in the 600 IU/kg weekly group (1.44 g/dL) was twice than that observed in the 300 IU/kg daily group (0.73 g/dL).
Slovenian: Od začetka predhodnega zdravljenja do časa pred kirurškim posegom je bilo povprečno povečanje hemoglobina v skupini s 600 i.e./kg na teden (1,44 g/dl) dvakrat večje od opaženega v skupini s 300 i.e./kg na dan (0,73 g/dl).
English: Epoetin alfa has been shown to stimulate red blood cell production in order to augment autologous blood collection, and to limit the decline in haemoglobin in adult patients scheduled for major elective surgery who are not expected to predeposit their complete perioperative blood needs.
Slovenian: Odrasli bolniki, naročeni na kirurški poseg, ki sodelujejo v avtolognem preddonorskem programu Pokazalo se je, da epoetin alfa spodbuja nastajanje rdečih krvnih celic z namenom povečanja odvzema avtologne krvi in zmanjšanja upada hemoglobina pri odraslih bolnikih, naročenih na večji elektivni kirurški poseg, pri katerih se ne pričakuje, da bodo zbrali kri za vse njihove potrebe pri operaciji.
English: In repeated dose toxicological studies in dogs and rats, but not in monkeys, epoetin alfa therapy was associated with subclinical bone marrow fibrosis.
Slovenian: 5.3 Predklinični podatki o varnosti Nekatere toksikološke študije pri ponavljajočih odmerkih na psih in podganah, toda ne na opicah, so pokazale, da je zdravljenje z epoetinom alfa povezano s subklinično fibrozo kostnega mozga.
English: Binocrit is a sterile but unpreserved product and is for single use only.
Slovenian: Zdravilo Binocrit je sterilno, brez dodatka konzervansa, namenjeno zgolj enkratni uporabi.
English: The half-life of epoetin alfa following multiple dose intravenous administration is approximately 4 hours in healthy subjects.
Slovenian: Razpolovni čas epoetina alfa po intravenskem injiciranju več odmerkov je pri zdravih osebah približno 4 ure.
English: Instructions on how to inject Binocrit yourself
Slovenian: Navodila, kako si sami injicirate zdravilo Binocrit
English: Some people, depending on why they need Binocrit treatment, may later learn how to inject themselves under the skin: see Instructions on how to inject Binocrit yourself at the end of the leaflet.
Slovenian: Nekateri posamezniki se lahko kasneje naučijo, kako si lahko zdravilo sami injicirajo pod kožo, odvisno od tega, za kaj potrebujejo zdravilo Binocrit: glejte
English: Instructions on how to inject yourself with Binocrit can be found at the end of this leaflet.
Slovenian: Navodila za to, kako si sami injicirate zdravilo Binocrit, lahko najdete na koncu tega navodila za uporabo zdravila.
English: Alternatively, Binocrit can be administered at an initial dose of 450 IU/kg subcutaneously once weekly.
Slovenian: Alternativno se lahko zdravilo Binocrit daje enkrat na teden, z začetnim odmerkom 450 i.e./kg,
English: Where intravenous access is not readily available Binocrit may be administered subcutaneously.
Slovenian: Kjer intravenski dostop ni takoj na razpolago, se zdravilo Binocrit lahko daje subkutano.
English: Only take one dose of Binocrit from each syringe.
Slovenian: Uporabite le en odmerek zdravila Binocrit iz vsake injekcijske brizge.
English: In cases where there is a medical need to shorten the lead time before surgery to less than three weeks, Binocrit 300 IU/kg should be administered subcutaneously daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter.
Slovenian: Kadar moramo zaradi zdravstvenih razlogov skrajšati čas pred kirurškim posegom na manj kot tri tedne, je treba dajati 300 i.e./kg zdravila Binocrit subkutano na dan, in sicer 10 dni zapored pred kirurškim posegom, na dan kirurškega posega in še štiri dni takoj po njem.
English: Binocrit should be administered as a subcutaneous injection.
Slovenian: Zdravilo Binocrit je treba dati v obliki subkutane injekcije.
English: What is in this leaflet What Binocrit is and what it is used for What you need to know before you use Binocrit How to use Binocrit Possible side effects How to store Binocrit Contents of the pack and other information What Binocrit is and what it is used for Binocrit contains the active substance epoetin alfa, a protein that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen).
Slovenian: Kaj je zdravilo Binocrit in za kaj ga uporabljamo Zdravilo Binocrit vsebuje zdravilno učinkovino epoetin alfa, beljakovino, ki spodbuja kostni mozeg k tvorbi rdečih krvnih celic, ki prenašajo hemoglobin (snov, ki prenaša kisik).
English: Binocrit 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 2,000 IU/1 mL solution for injection in a pre-filled syringe Binocrit 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Binocrit 4,000 IU/0.4 mL solution for injection in a pre-filled syringe Binocrit 5,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 6,000 IU/0.6 mL solution for injection in a pre-filled syringe Binocrit 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Binocrit 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Binocrit 9,000 IU/0.9 mL solution for injection in a pre-filled syringe Binocrit 10,000 IU/1 mL solution for injection in a pre-filled syringe Binocrit 20,000 IU/0.5 mL solution for injection in a pre-filled syringe Binocrit 30,000 IU/0.75 mL solution for injection in a pre-filled syringe Binocrit 40,000 IU/1 mL solution for injection in a pre-filled syringe
Slovenian: Binocrit 1.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 2.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 3.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 4.000 i.e./0,4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 5.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 6.000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 7.000 i.e./0,7 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 8.000 i.e./0,8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 9.000 i.e./0,9 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 20.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 30.000 i.e./0,75 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Binocrit 40.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Binocrit contains sodium
Slovenian: Zdravilo Binocrit vsebuje natrij
English: Stop using Binocrit if you develop these symptoms and contact your doctor or seek medical attention immediately.
Slovenian: Če se pri vas pojavijo ti simptomi, prenehajte uporabljati zdravilo Binocrit in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: In patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration of Binocrit by the intravenous route is preferable.
Slovenian: Pri bolnikih s kronično ledvično odpovedjo, pri katerih je intravenski dostop rutinsko na razpolago (bolniki na hemodializi), je zaželeno intravensko dajanje zdravila Binocrit.
English: Binocrit contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”.
Slovenian: Zdravilo Binocrit vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni „brez natrija“.