natgillin/translations-raw huggingface dataset:
• Only use Retacrit if it has been stored correctly - see section 5, How to Store Retacrit.
• Zdravilo Retacrit uporabljajte samo, če je bilo ustrezno hranjeno - glejte poglavje 5, Kako shranjevati zdravilo Retacrit.
A.LABELLING
A. OZNAČEVANJE
The cause of your anaemia is also a factor in your doctor deciding the correct dose.
Vzrok vaše anemije je ravno tako dejavnik, ki ga zdravnik uporablja pri določanju pravega odmerka.
• Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria).
• Težava s krvjo, ki lahko povzroči bolečino, temno obarvan urin ali zvečanje občutljivosti kože na sončno svetlobo (porfirija).
If the product has been shaken vigorously, don't use it.
Če je bilo zdravilo izpostavljeno močnemu stresanju, ga ne uporabite.
Do not use this medicine if you notice that the seal is broken or if the liquid is coloured or you can see particles floating in it.
Ne uporabljajte tega zdravila, če opazite, da je pečat pretrgan ali če je tekočina obarvana ali v njej videti plavati delce.
Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Kirurški bolniki, ki iz kakršnegakoli razloga ne morejo prejemati ustrezne profilakse proti trombozi.
If you are within a day of your next injection, forget the missed one and carry on with your normal schedule.
Če je do vaše naslednje injekcije še en dan ali manj, pozabite na izpuščeno injekcijo in nadaljujte po svojem običajnem urniku.
Retacrit may not be suitable for you.
Zdravilo Retacrit za vas morda ni primerno.
The liquid needs to come to room temperature.
Tekočina se mora ogreti na sobno temperaturo.
• Once your anaemia has been corrected, your doctor will continue to check your blood regularly.
• Ko je anemija odpravljena, bo zdravnik še naprej redno preverjal vašo kri.
ESAs are not indicated for use in this patient population,
Zdravila ESA niso indicirana za uporabo pri tej populaciji bolnikov;
Push it slowly and evenly, keeping the skin fold pinched.
Potiskajte enakomerno in počasi, kožna guba naj bo ves čas pridvignjena.
• Your doctor will order regular blood tests to see how your anaemia is responding and may adjust the dose, usually no more frequently than every four weeks.
• Vaš zdravnik bo redno opravljal preiskave krvi, da vidi, kako se vaša anemija odziva, ter lahko odmerek prilagodi, običajno ne pogosteje kot na vsake 4 tedne.
• If you have high blood pressure not properly controlled with medicines.
• če imate visok krvni tlak, ki ga z zdravili ni možno kontrolirati.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life-expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1).
Dejavnike, ki bi jih morali upoštevati pri tej oceni, morajo vključevati tip tumorja in njegov stadij, stopnjo anemičnosti, pričakovano življenjsko dobo, okolje v katerem se bolnika zdravi in prednosti za bolnika (glejte poglavje 5.1).
Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4).
Krvni tlak je treba redno spremljati, še posebej na začetku zdravljenja (glejte poglavje 4.4).
• For patients on peritoneal dialysis Retacrit may be given twice a week.
• Pri bolnikih na peritonealni dializi se lahko zdravilo Retacrit daje dvakrat tedensko.
The apparent molecular weight of erythropoietin is 32 000 to 40 000 dalton.
Navidezna molekulska masa eritropoetina je med 32.000 in 40.000 daltoni.
• Do not remove the needle cover from the pre-filled syringe until you are ready to inject your medicine.
• Ne odstranite pokrovčka igle z napolnjene injekcijske brizge, dokler niste pripravljeni na injiciranje zdravila.
All special warnings and special precautions associated with autologous predonation programmes, especially routine volume replacement, should be respected.
Upoštevati je treba vsa posebna opozorila in previdnostne ukrepe, povezane z avtolognimi preddonorskimi programi, zlasti rutinsko nadomeščanje tekočine.
• Choose an injection site.
• Izberite mesto za injiciranje.
Patients from the group treated with epoetin alfa were also enrolled in an open-label extension study which demonstrated improvements in their quality of life that were maintained for an additional 12 months.
Bolnike iz skupine, ki se je zdravila z epoetinom alfa, so vključili tudi v odprto podaljšano študijo, s katero so dokazali izboljšanje kakovosti njihovega življenja, ki so jo ohranjali še 12 mesecev.
Your doctor will help you to decide if Retacrit is suitable for you.
Zdravnik vam bo pomagal pri odločitvi, ali je zdravilo Retacrit primerno za vas.
After EPO binds to its cell surface receptor, it activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation.
Ko se EPO veže na svoj površinski receptor, aktivira poti prenosa signalov, ki motijo apoptozo in spodbujajo proliferacijo eritroidnih celic.
After 52 weeks, 57% of patients remained in the study, receiving a median dose of 200 IU/kg/week.
Po 52 tednih je v študiji ostalo še 57 % bolnikov, ki so prejemali mediani odmerek 200 i.e./kg/teden.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
V štirih s placebom nadzorovanih študijah so bila razmerja tveganj za skupno preživetje v razponu od 1,25 in 2,47 v prid kontrolam.
If blood pressure cannot be controlled, epoetin zeta treatment should be discontinued.
Če krvnega tlaka ni mogoče obvladati, je treba zdravljenje z epoetinom zeta prekiniti.
If you can't take medicines that prevent blood clotting, you must not have Retacrit.
Če ne smete jemati zdravil, ki preprečujejo strjevanje krvi, zdravila Retacrit ne smete jemati.
Consequently, epoetin zeta should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Zato se med nosečnostjo epoetin zeta sme uporabljati le, če možne koristi odtehtajo možna tveganja za plod.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Usually the injections will be given to you by a doctor, nurse or other health care professional.
Običajno vam bo injekcije dajal zdravnik, medicinska sestra ali drug zdravstveni delavec.
This risk may be higher if you have other risk factors for developing blood clots (for example, if you have had a blood clot in the past or are overweight, have diabetes, have heart disease or you are off your feet for a long time because of surgery or illness).
To tveganje je lahko večje, če imate druge dejavnike tveganja za nastanek krvnih strdkov (če ste na primer imeli krvni strdek v preteklosti ali imate prekomerno telesno težo, sladkorno bolezen, bolezen srca ali morate ležati zaradi kirurškega posega ali bolezni).
• Always use Retacrit exactly as instructed by your doctor or nurse.
• Vedno zdravilo Retacrit uporabite natančno tako, kot sta vas naučila zdravnik ali medicinska sestra.
Epoetin zeta should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
Epoetin zeta je treba previdno uporabljati pri nezdravljeni, nezadostno zdravljeni ali slabo obvladljivi hipertenziji.
• To stimulate the production of your red blood cells (so that doctors can take more blood from you) if you cannot have transfusions with your own blood during or after surgery.
• za spodbujanje tvorbe vaših rdečih krvnih celic (tako da vam lahko zdravniki odvzamejo več krvi), če med operacijami ali po njih ne morete prejeti transfuzij svoje lastne krvi.
Headaches, particularly sudden, stabbing migraine-like headaches, feeling confused or having fits may be signs of a sudden increase in blood pressure.
Glavoboli, še posebej nenadni, migreni podobni glavoboli z zbadanjem, zmedenost ali napadi so lahko znaki nenadnega povečanja krvnega tlaka.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2 833 patients, of which four were double-blind placebo-controlled studies and one was an open-label study.
Preživetje in napredovanje tumorjev so raziskovali v 5 velikih kontroliranih študijah, v katere je bilo vključenih vsega skupaj 2.833 bolnikov, od katerih so bile štiri študije dvojno slepe in nadzorovane s placebom, ena pa je bila študija odprtega tipa.
If the medicinal product has not been used at the end of this period, it should be disposed of.
Če zdravila ne porabite do konca tega obdobja, ga morate zavreči.
Your Retacrit dose and frequency of administration may be further adjusted to maintain your response to treatment.
Vaš odmerek zdravila Retacrit in pogostnost dajanja lahko nadalje prilagaja z namenom vzdrževati vaš odziv na zdravljenje.
Treatment with Retacrit has to be initiated under the supervision of physicians experienced in the management of patients with above indications.
Zdravljenje z zdravilom Retacrit je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z zgoraj navedenimi indikacijami.
This temperature range should be closely maintained until administration to the patient.
Ta temperaturni razpon je treba natančno ohranjati do injiciranja bolniku.
Medicinal products that decrease erythropoiesis may decrease the response to epoetin zeta.
Zdravila, ki zmanjšujejo eritropoezo, lahko zmanjšajo odziv na epoetin zeta.
In general, all pharmacodynamic markers increased in a linear manner with dose reaching a maximum response at the highest dose levels.
Na splošno so se farmakodinamični kazalci povečevali linearno z odmerkom, z največjim odzivom ob največjih odmerkih.
Retacrit can reduce the need for a blood transfusion.
Zdravilo Retacrit lahko zmanjša potrebo po transfuziji krvi.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Retacrit therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Retacrit, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
If Retacrit is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 ml) in a single injection.
Če si zdravilo Retacrit injicirate pod kožo (subkutano), injicirana količina običajno ne preseže enega mililitra (1 ml) v posamezni injekciji.
Your doctor has carried out blood tests and decided you need Retacrit.
Vaš zdravnik je opravil preiskave krvi in presodil, da potrebujete zdravilo Retacrit.
Hyperkalaemia has been observed in isolated cases though causality has not been established.
V posameznih primerih so opazili hiperkaliemijo, čeprav zanjo niso odkrili vzroka.
In all patients receiving epoetin zeta, blood pressure should be closely monitored and controlled as necessary.
Pri vseh bolnikih, ki prejemajo epoetin zeta, moramo skrbno preverjati krvni tlak in ga po potrebi nadzorovati.
Contains phenylalanine, see leaflet for further information.
Vsebuje fenilalanin, glejte navodilo za uporabo za dodatno informacijo.
After approximately two months of therapy, virtually all patients were transfusion-independent.
Po približno dveh mesecih zdravljenja skoraj noben bolnik ni bil odvisen od transfuzije.
• Either into a vein or a tube that goes into a vein (intravenously)
• bodisi v veno ali v cevko, ki vstopa v veno (intravensko)
The haemoglobin response varies between patients and may be impacted by iron stores and the presence of concurrent medical problems.
Odziv vrednosti hemoglobina se med bolniki razlikuje, nanjo pa lahko vplivajo zaloge železa in prisotnost sočasnih zdravstvenih težav.
In some studies, the double-blind phase was followed by an open-label phase during which all patients received epoetin alfa and a maintenance of effect was observed.
V nekaterih študijah je dvojno slepi fazi sledila odprta faza, v kateri so vsi bolniki prejemali epoetin alfa in kjer so opazili vzdrževanje učinka.
It is unknown whether exogenous epoetin zeta is excreted in human milk.
Ni znano, ali se eksogeni epoetin zeta izloča v materino mleko.
It is important to tell your doctor if any of the following apply to you.
Pomembno je, da zdravniku poveste, če za vas velja karkoli od naslednjega.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim ali pa boste morda začeli jemati katero koli drugo zdravilo.
Later, your doctor may suggest that you or your caregiver learn how to inject Retacrit under the skin (subcutaneously) yourself.
Pozneje vam lahko zdravnik predlaga, da se vi ali vaš skrbnik naučite, kako si zdravilo Retacrit injicirate pod kožo (subkutano) sami.
Iron supplements and other blood stimulants may increase the effectiveness of Retacrit.
Dodatki železa in drugi spodbujevalci tvorbe krvi lahko povečajo učinkovitost zdravila Retacrit.
Two other smaller, randomised, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Dve drugi manjši, randomizirani, s placebom kontrolirani preskušanji nista ugotovili signifikantnega napredka v parametrih kvalitete življenja, merjenih s skalama EORTC-QLQ-C30 oziroma CLAS.
In controlled clinical studies, use of epoetin zeta and other ESAs have been associated with decreased locoregional tumour control or decreased overall survival:
V nadzorovanih kliničnih študijah so uporabo epoetina zeta in drugih ESA povezali z zmanjšanim lokoregionalnim nadzorom tumorja ali skrajšanim celokupnim preživetjem:
While on Retacrit, some people need medicines to reduce the risk of blood clots.
Ob jemanju zdravila Retacrit nekateri ljudje potrebujejo zdravila za zmanjšanje tveganja krvnih strdkov.
Overdosage of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone.
Prevelik odmerek eritropoetina ima lahko posledice v obliki podaljšanja farmakoloških učinkov hormona.
This is of uncertain significance in the clinical situation.
Pomen tega v kliničnih okoliščinah ni znan.
The needle guard will NOT activate unless the ENTIRE dose has been given.
Pripomoček za zaščito igle se NE bo aktiviral, dokler ne injicirate CELOTNEGA odmerka.
If you have kidney disease, you may be short of red blood cells if your kidney does not produce enough erythropoietin (necessary for red cell production).
Če imate bolezen ledvic, vam lahko primanjkuje rdečih krvnih celic, če vaši ledvici ne proizvajata dovolj eritropoetina (potrebnega za tvorbo rdečih krvnih celic).
Continue bending the needle until the syringe exceeds a 45 degree angle with the flat surface to render it permanently unusable.
Iglo upogibajte, dokler brizga ne preseže kota 45 stopinj glede na ravno podlago, s čimer postane igla trajno neuporabna.
• have recently had a heart attack or stroke
• ste pred kratkim doživeli srčni infarkt ali možgansko kap,
Precautions to be taken before handling or administering the medicinal product.
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila.
Retacrit is a biosimilar medicinal product.
Retacrit je biološko podobno zdravilo.
This includes patients on dialysis and patients not yet on dialysis.
To vključuje bolnike na dializi in bolnike, ki še niso na dializi.
The injections should be given in the limbs or the anterior abdominal wall.
Injekcije je treba dajati v ude ali sprednjo trebušno steno.
Tell the doctor or nurse immediately if you think too much Retacrit has been injected.
Zdravniku ali medicinski sestri nemudoma povejte, če mislite, da vam je bilo injicirano preveč zdravila Retacrit.
• If you are a cancer patient be aware that products that stimulate red blood cell production (like Retacrit) may act as a growth factor and therefore in theory may affect the progression of your cancer.
• Če ste bolnik z rakom, morate vedeti, da lahko zdravila, ki spodbujajo tvorbo rdečih krvnih celic (tako kot zdravilo Retacrit), delujejo kot rastni dejavnik in kot takšna lahko teoretično vplivajo na napredovanje vašega raka.
• If you do not respond adequately to Retacrit, your doctor will check your dose and will inform you if you need to change doses of Retacrit.
• Če se na zdravilo Retacrit ne odzivate ustrezno, bo zdravnik preveril vaš odmerek in vas obvestil, če ga morate spremeniti.
The decision to administer recombinant erythropoietin treatment should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Odločitev glede dajanja rekombinantnih eritropoetinov mora temeljiti na oceni koristi in tveganj ob sodelovanju posameznega bolnika, pri tem pa bi bilo treba upoštevati specifično klinično situacijo.
These changes are interpreted as being secondary to decreased maternal body weight gain, and the significance to humans is unknown given therapeutic dose levels.
Razlogi so, da so te spremembe sekundarne posledice znižane rasti telesne mase pri materah, pomen za ljudi pa glede na ravni terapevstkih odmerkov ni znan.
Once the target haematocrit was achieved, the maintenance dose was individualised for each patient.
Ko so dosegli ciljno vrednost hematokrita, so vzdrževalni odmerek prilagodili posameznemu bolniku.
Conflicting reports in the literature, based on in vitro findings from human tumour samples, suggest erythropoietins may play a role as tumour proliferators.
Nasprotujoča si poročila v literaturi, ki temeljijo na in vitro ugotovitvah pri vzorcih človeških tumorjev, kažejo na to, da imajo lahko eritropoetini vlogo kot tumorski proliferatorji.
• If you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:
• če ste naročeni na večji elektivni ortopedski kirurški poseg (kot je operacija kolka ali kolena) in:
Do not administer Retacrit by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Zdravila Retacrit ne injicirajte z intravensko infuzijo ali skupaj z raztopinami drugih zdravil (za dodatne informacije glejte poglavje 6.6).
What Retacrit is and what it is used for
Kaj je zdravilo Retacrit in za kaj ga uporabljamo
During the maintenance phase, Retacrit can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Med vzdrževalno fazo se zdravilo Retacrit lahko daje bodisi trikrat tedensko in v primeru subkutanega dajanja enkrat tedensko ali enkrat na vsaka dva tedna.
• Check the syringe, to make sure it is the right dose, has not passed its expiry date, is not damaged, and the liquid is clear and not frozen.
• Preverite, da imate v brizgi pravilen odmerek, da rok uporabe ni pretečen, da brizga ni poškodovana in da je raztopina bistra in nezamrznjena.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Receptorji za eritropoetin so lahko izraženi na površini številnih tumorskih celic.
Don't squeeze it.
Ne stiskajte je.
Of the patients who achieved the target, 90% did so on a 3 times-per-week dosing regimen.
Pri 90 % bolnikov, ki so dosegli cilj, je bil režim odmerjanja trikrat na teden.
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Nadzorovana klinična preskušanja niso pokazala pomembnih koristi, ki bi jih lahko pripisali epoetinom, kadar se koncentracijo hemoglobina poveča čez raven, ki je potrebna za nadzorovanje simptomov anemije in izogibanje transfuziji krvi.
Retacrit is given alone and not mixed with other liquids for injection.
Zdravilo Retacrit se daje samostojno in se ga ne meša z drugimi tekočinami za injiciranje.
Other medicines and Retacrit
Druga zdravila in zdravilo Retacrit
You should discuss this with your doctor because a combination of epoetin zeta with interferon and ribavirin has led to a loss of effect and development of a condition called pure red cell aplasia (PRCA), a severe form of anaemia, in rare cases.
O tem se morate posvetovati s svojim zdravnikom, saj je kombinacija epoetina zeta z interferonom in ribavirinom v redkih primerih povzročila izgubo učinka in nastanek stanja, ki ga imenujemo čista aplazija rdečih krvnih celic (PRCA - pure red cell aplasia), hude oblike anemije.
• if the liquid is coloured or you can see particles floating in it,
• če je tekočina obarvana ali če so v njej vidni plavajoči delci,
There are no studies assessing the potential effect of epoetin zeta on male or female fertility.
Ni študij, s katerimi bi ocenili možen vpliv epoetina zeta na plodnost moških ali žensk.
Recombinant human EPO (epoetin zeta), expressed in Chinese hamster ovary cells, has a 165 amino acid sequence identical to that of human urinary EPO; the 2 are indistinguishable on the basis of functional assays.
Rekombinantni humani EPO (epoetin zeta), izražen v ovarijskih celicah kitajskega hrčka, ima 165 aminokislin dolgo zaporedje, identično tistemu, ki ga ima EPO v človeškem urinu; teh 2 ni mogoče ločiti na podlagi funkcionalnih preskusov.
• If you are a patient with chronic renal failure, and particularly if you do not respond properly to Retacrit, your doctor will check your dose of Retacrit because repeatedly increasing your dose of Retacrit if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
• Če ste bolnik s kronično ledvično okvaro, zlasti če se na zdravilo Retacrit ne odzivate ustrezno, bo zdravnik spremljal vaš odmerek zdravila Retacrit, ker ponavljajoče se zviševanje odmerka zdravila Retacrit, če se na zdravljenje ne odzivate, lahko poveča tveganje za težave s srcem ali krvnimi žilami in lahko poveča tveganje za srčni infarkt, možgansko kap in smrt.
• Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Retacrit treatment.
• Vaš zdravnik bo naročil krvne preiskave in morda prilagodil odmerek, odvisno od tega, kako se anemija odziva na zdravljenje z zdravilom Retacrit.
• epileptic seizures or fits
• epileptične napade ali krče
What you need to know before you use Retacrit
Kaj morate vedeti, preden boste uporabili zdravilo Retacrit
If you visit a hospital, clinic or family doctor, tell them you are having Retacrit treatment.
Če boste obiskali bolnišnico, drugo zdravstveno ustanovo ali osebnega zdravnika, jim povejte, da se zdravite z zdravilom Retacrit.
Epoetin alfa does not induce bacterial gene mutation (Ames Test), chromosomal aberrations in mammalian cells, micronuclei in mice, or gene mutation at the HGPRT locus.
Epoetin alfa ne inducira bakterijske genetske mutacije (Amesov test), kromosomskih aberacij v celicah sesalcev, mikronukleusov pri miših ali genskih mutacij na lokusu HGPRT.
Because Retacrit stimulates the production of red blood cells, doctors can take more blood from these people.
Ker zdravilo Retacrit spodbuja tvorbo rdečih krvnih celic, lahko zdravniki tem osebam odvzamejo več krvi.
• For adults and children Retacrit is given as an injection either into a vein (intravenously) or a tube that goes into a vein.
• Pri odraslih in otrocih zdravilo Retacrit dajemo v obliki injekcije bodisi v veno (intravensko) bodisi po cevki, ki vodi v veno.
Extending dose intervals may require an increase in dose.
Pri podaljšanih odmernih intervalih bo morda treba zvišati odmerek.
If you forget to use Retacrit
Če ste pozabili uporabiti zdravilo Retacrit
Please discuss this with your doctor.
O tem se posvetujte s svojim zdravnikom.
Instructions on how to inject Retacrit yourself
Navodila o tem, kako si zdravilo Retacrit injicirate sami