natgillin/translations-raw huggingface dataset:
It should be allowed to reach a comfortable temperature (15 °C - 25 °C) for injection.
Za injiciranje mora doseči prijetno temperaturo (15 °C-25 °C).
The decision to administer recombinant erythropoietins 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 za uporabo rekombinantnih eritropoetinov mora temeljiti na oceni razmerja med koristjo in tveganjem pri posameznem bolniku, ki mora upoštevati poseben klinični kontekst.
This medicine does not affect your ability to drive and use machines.
To zdravilo ne vpliva na sposobnost vožnje in upravljanja s stroji.
The safety device prevents needle stick injuries after use, so no special precautions for disposal are required.
Varnostni pripomoček preprečuje poškodbe zaradi vboda z iglo po uporabi, tako da posebni varnostni ukrepi za odstranjevanje niso potrebni.
It is unknown whether epoetin theta/metabolites are excreted in human milk, but data in neonates show no absorption or pharmacological activity of erythropoietin when given together with breast milk.
Ni znano, ali se epoetin theta/presnovki izločajo v materino mleko, vendar podatki pri novorojenčkih ne kažejo absorpcije ali farmakološke dejavnosti eritropoetina, kadar se daje skupaj z materinim mlekom.
The expiry date refers to the last day of that month.
če je ta pretekel zadnji dan navedenega meseca.
If this blood parameter becomes too high, heart or vascular problems might occur, increasing the risk of death.
Če se ta krvni parameter preveč poveča, se lahko pojavijo srčne in žilne težave, kar poveča tveganje smrti.
Biopoin is used for the treatment of anaemia accompanied by symptoms (for example fatigue, weakness and shortness of breath).
Zdravilo Biopoin se uporablja za zdravljenje anemije s simptomi (na primer utrujenost, šibkost in kratka sapa).
Otherwise the increased number of red blood cells may cause blocking of the arterio-venous fistula (an artificial connection between an artery and a vein which is surgically prepared in dialysis patients).
Drugače lahko povečano število rdečih krvničk blokira arteriovensko fistulo (umetno zvezo med arterijo in veno, ki se kirurško pripravi pri bolnikih na dializi).
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 openlabel study.
Preživetje in napredovanje tumorjev so preučili v petih velikih nadzorovanih študijah, ki so skupno vključile 2833 bolnikov, od katerih so bile štiri dvojno slepe, s placebom nadzorovane študije, ena pa odprta študija.
If you are already taking a medicine to reduce your blood pressure, your doctor might increase the dose.
Če že jemljete zdravila za zniževanje krvnega tlaka, bo zdravnik morda povečal odmerek.
If you feel tired and weak or experience breathlessness, you must consult your doctor.
Če ste utrujeni, šibki ali brez sape, se morate o tem posvetovati z zdravnikom.
Following subcutaneous injection of 40 IU/kg body weight epoetin theta at three different sites (upper arm, abdomen, thigh) in healthy volunteers, similar plasma level profiles were observed.
Po subkutanem injiciranju 40 i.e./kg telesne mase epoetina theta na treh različnih mestih (zgornjem delu roke, abdomnu, stegnu) pri zdravih prostovoljcih so opazili podobne profile ravni v plazmi.
If you do not respond adequately to Biopoin, your doctor will check your dose and will inform you if you need to change doses of Biopoin.
Če se na zdravilo Biopoin ne odzovete ustrezno, bo zdravnik vaš odmerek preveril in vas obvestil, ali je treba odmerke zdravila Biopoin zamenjati.
Animal studies with other epoetins do not indicate direct harmful effects with respect to reproductive toxicity (see section 5.3).
Študije pri živalih z drugimi epoetini ne kažejo neposrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
Pull straight as shown in picture 4.
Potegnite naravnost, kot je prikazano na sliki 4.
Average bioavailability of epoetin theta after subcutaneous administration is approximately 31% compared with intravenous administration.
Povprečna biološka uporabnost epoetina theta po subkutani uporabi je v primerjavi z intravensko uporabo približno 31-odstotna.
You may experience the following additional side effects:
Imate lahko tudi naslednje neželene učinke:
The biological efficacy of epoetin theta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (mice, rats, dogs).
Predklinična učinkovitost Biološko učinkovitost epoetina theta so pokazali po intravenski in subkutani uporabi pri različnih živalskih modelih in vivo (miših, podganah, psih).
- Hypersensitivity to the active substance, other epoetins and derivatives or to any of the excipients listed in section 6.1.
- Preobčutljivost za zdravilno učinkovino, druge epoetine in derivate ali katero koli pomožno snov, navedeno v poglavju 6.1.
In patients with chronic renal failure, the maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Pri bolnikih s kronično ledvično okvaro vzdrževalna koncentracija hemoglobina ne sme preseči zgornje meje ciljne koncentracije hemoglobina, priporočene v poglavju 4.2.
The production of erythropoietin primarily occurs in and is regulated by the kidney in response to changes in tissue oxygenation.
Eritropoetin se primarno tvori in regulira v ledvicah kot odziv na spremembe v oksigenaciji tkiva.
Your doctor will check that you do not have other causes of anaemia and may perform blood tests or examine your bone marrow.
Zdravnik bo preveril, ali imate druge vzroke za anemijo, in morda opravil krvne preiskave ali preiskavo kostnega mozga.
A reticulocyte count should be considered as part of the evaluation.
Kot del ocene je treba razmisliti o preiskavi števila retikulocitov.
If your doctor suspects or confirms that you have this condition, you must not be treated with Biopoin or another epoetin.
Če zdravnik sumi na to stanje ali ga potrdi, se ne smete zdraviti z zdravilom Biopoin ali drugim epoetinom.
- Never put the syringes that you have used into your normal household rubbish bin.
- Uporabljenih brizg nikoli ne zavrzite v gospodinjski koš za odpadke.
Pull straight as shown in picture 5.
Potegnite naravnost, kot je prikazano na sliki 5.
The injection will be given once-weekly.
Injekcija se bo dajala enkrat na teden.
Once removed from the refrigerator, the medicinal product must be used within this period or disposed of.
Ko se zdravilo vzame iz hladilnika, ga je treba v tem obdobju uporabiti ali zavreči.
The needle will be shielded and locked automatically so that you can not prick yourself (see picture 12).
Igla se bo samodejno zaščitila in zaskočila, tako da se ne morete zbosti (glejte sliko 12).
The haemoglobin levels remained within the desired target range and epoetin theta was well tolerated over a period of up to 15 months.
Ravni hemoglobina so ostale znotraj želenega ciljnega razpona, bolniki pa so epoetin theta dobro prenašali do 15 mesecev.
If your blood pressure rises, your doctor may give you medicines to reduce your blood pressure.
Če se krvni tlak zviša, vam bo zdravnik morda predpisal zdravila za zniževanje krvnega tlaka.
Do not touch the needle or push the plunger.
Ne dotikajte se igle in ne potiskajte bata.
As a precautionary measure, it is preferable to avoid the use of Biopoin during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Biopoin bolje izogibati.
Push the plunger up to the number (IU) on the syringe that matches the dose of Biopoin that your doctor prescribed.
Bat potisnite do številke (i.e.), ki ustreza odmerku zdravila Biopoin, ki ga je predpisal zdravnik.
The use of this medicine by healthy people can excessively increase certain blood parameters and in so doing cause problems with the heart or blood vessels that can be life threatening.
Uporaba tega zdravila pri zdravih ljudeh lahko čezmerno poveča nekatere krvne parametre, kar lahko povzroči težave s srcem in krvnimi žilami, ki so lahko smrtno nevarne.
In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the increase in haemoglobin and the target haemoglobin value should be determined individually taking into account the clinical picture.
Ob hipertenziji ali obstoječi kardiovaskularni, cerebrovaskularni ali periferni vaskularni bolezni je treba povečanje vrednosti hemoglobina in ciljno vrednost hemoglobina določiti individualno, pri čemer je treba upoštevati klinično sliko.
The first study was conducted in 186 anaemic patients with non-myeloid malignancies (55% with haematological malignancies and 45% with solid tumours) receiving non-platinum chemotherapy.
Prva študija se je opravila pri 186 anemičnih bolnikih z nemieloidnimi malignostmi (55 % s hematološkimi malignostmi in 45 % s solidnimi tumorji), ki so prejemali kemoterapijo brez platine.
Frequency groupings are defined according to the following convention:
Pogostnosti so opredeljene glede na naslednje: Zelo pogosti:
Once an adequate number of red blood cells has been reached, the maintenance dose required to keep the number constant will be determined by your doctor.
Ko se doseže zadostno število rdečih krvničk, bo zdravnik določil vzdrževalni odmerek, potreben za ohranjanje stalnega števila rdečih krvničk.
Patients on haemodialysis will usually receive the injection at the end of dialysis via an arterio-venous fistula.
Bolniki na hemodializi bodo injekcijo navadno prejeli po koncu dialize prek arteriovenske fistule.
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.
V obeh študijah je zdravljenje z epoetinom theta povzročilo pomemben hemoglobinski odziv (p < 0,001), opredeljen kot povečanje koncentracije hemoglobina za ≥ 2 g/dl brez transfuzije, in pomembno zmanjšanje potrebe po transfuziji (p < 0,05) v primerjavi s placebom.
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.
Zaradi omejenih izkušenj učinkovitosti in varnosti epoetina theta ni bilo mogoče oceniti pri bolnikih z oslabljenim delovanjem jeter ali homozigotno anemijo srpastih celic.
Two of the studies recruited patients who were being treated with chemotherapy.
Dve od teh študij sta vključili bolnike, ki so se zdravili s kemoterapijo.
As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy (see section
Kot pri vseh rastnih faktorjih tudi pri epoetinih obstaja tveganje, da bodo stimulirali rast katere koli vrste malignosti (glejte poglavje 5.1).
Anaemia in cancer patients
Anemija pri bolnikih z rakom
In addition, the iron level in your blood will be checked before and during treatment with this medicine.
Poleg tega bodo pred zdravljenjem s tem zdravilom in med njim preverjali raven železa v krvi.
Treatment with Biopoin is normally a long-term therapy.
Zdravljenje z zdravilom Biopoin je navadno dolgotrajno.
Do not attempt to give this medicine to yourself without this training.
Zdravila Biopoin si ne poskušajte dati sami brez usposabljanja.
If you are on dialysis, medicines that prevent blood coagulation are used.
Če ste na dializi, se uporabljajo zdravila, ki preprečujejo strjevanje krvi.
In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Glede na navedeno je v nekaterih kliničnih primerih krvna transfuzija boljše zdravljenje za obravnavo anemije pri bolnikih z rakom.
You can now use the pre-filled syringe.
Zdaj lahko uporabite napolnjeno injekcijsko brizgo.
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
V več nadzorovanih študijah epoetini niso pokazali izboljšanja preživetja ali zmanjšanja tveganja napredovanja tumorja pri bolnikih z anemijo, povezano z rakom.
Only use each syringe for one injection.
Eno brizgo uporabite samo za eno injiciranje.
PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia.
pomeni, da je telo prenehalo ali zmanjšalo tvorbo rdečih krvničk, kar povzroča hudo anemijo.
How to prepare for your injection
Kako se pripravite na injiciranje
If you are a patient with chronic renal failure, and particularly if you do not respond properly to Biopoin, your doctor will check your dose of Biopoin because repeatedly increasing your dose of Biopoin 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 imate kronično ledvično odpoved, in še zlasti, če se na zdravilo Biopoin niste ustrezno odzvali, bo zdravnik večkrat preverjal vaš odmerek zdravila Biopoin, saj lahko, če se na zdravljenje ne odzivate, stalno povečevanje odmerka zdravila Biopoin poveča možnost za težave s srcem ali krvnimi žilami in lahko poveča tveganje za srčni infarkt, možgansko kap ali smrt.
Disposing of used syringes
Odstranjevanje uporabljenih brizg
It must be a clear and colourless liquid.
Tekočina mora biti prozorna in brezbarvna.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dl, is unclear because few patients with these characteristics were included in the data reviewed.
Ni jasno, v kolikšnem obsegu ti rezultati veljajo za uporabo rekombinantnega humanega eritropoetina pri bolnikih z rakom, ki se zdravijo s kemoterapijo, za doseganje koncentracij hemoglobina, manjših od 13 g/dl, saj je bilo v pregledane podatke vključenih malo bolnikov s temi značilnostmi.
In the clinical studies, patients not yet undergoing dialysis (subcutaneous administration) discontinued the study more frequently than haemodialysis patients (intravenous administration) as they had to terminate the study when starting dialysis.
V kliničnih študijah so bolniki, pri katerih se še ni opravljala dializa, (subkutana uporaba) študijo prekinili pogosteje kot bolniki na hemodializi (intravenska uporaba), saj so morali študijo prekiniti ob začetku dialize.
Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Zdravnik bo za nadzor simptomov vaše anemije uporabil najmajši učinkoviti odmerek.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Biopoin 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 Biopoin, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Check the appearance of Biopoin.
Preverite videz zdravila Biopoin.
Therefore, in patients treated with epoetin theta, special care should be taken to monitor closely and control blood pressure.
Zato je treba pri bolnikih, ki se zdravijo z epoetinom theta, skrbno spremljati in nadzorovati krvni tlak.
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when the 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, povezanih z dajanjem epoetinov, kadar je koncentracija hemoglobina večja od ravni, potrebne za nadzorovanje simptomov anemije in odsotnost krvne transfuzije.
Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO-K1) by recombinant DNA technology.
Epoetin theta (rekombinantni humani eritropoetin) se s tehnologijo rekombinantne DNA izdeluje v celicah jajčnika kitajskega hrčka (CHO-K1).
Following intravenous administration, the volume of distribution approximates to total blood volume.
Po intravenski uporabi je prostornina porazdelitve približno enaka kot skupna prostornina krvi.
Injections are given under the skin.
Injekcije se dajejo pod kožo.
During the evaluation period (weeks 15 to 26), the mean and median level of haemoglobin in patients treated with epoetin theta was virtually identical to their baseline haemoglobin level.
Med ocenjevanjem (od 15. do 26. tedna) je bila srednja in mediana raven hemoglobina pri bolnikih, ki so jih zdravili z epoetinom theta, skoraj enaka kot izhodiščna raven hemoglobina.
Treatment with epoetin theta is divided into two stages.
Zdravljenje z epoetinom theta poteka v dveh fazah.
If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe.
Če vidite zračne mehurčke, s prsti nežno potrkajte brizgo, dokler se mehurčki ne dvignejo na vrh brizge.
Pure red cell aplasia (PRCA)*
Bolezni krvi in limfatičnega sistema čista aplazija rdečih krvničk (PRCA)*
This section contains information on how to give yourself an injection of Biopoin under the skin.
To poglavje vsebuje informacije o samostojnem injiciranju zdravila Biopoin pod kožo.
If blood pressure values remain high, temporary interruption of epoetin theta therapy may be required.
Če je vrednost krvnega tlaka še vedno velika, bo morda treba začasno prekiniti zdravljenje z epoetinom theta.
The median time to response was similar in the treatment groups with 56 days in haemodialysis patients and 49 days in patients not yet undergoing dialysis.
Mediana časa do odziva je bila podobna v skupinah z bolniki, ki so se s tem zdravilom zdravili 56 dni in so prejemali hemodializo, in skupinah z bolniki, ki so se s tem zdravilom zdravili 49 dni in niso prejemali dialize.
Hypertension occurs in chronic renal failure patients more often during the correction phase than during the maintenance phase.
Hipertenzija se pri bolnikih s kronično ledvično odpovedjo pogosteje pojavi med korekcijsko fazo kot vzdrževalno fazo.
Contents of the pack and other information What Biopoin contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Biopoin
What you need to know before you use Biopoin Do NOT use Biopoin
Kaj morate vedeti, preden boste uporabili zdravilo Biopoin NE uporabljajte zdravila Biopoin
Check again to make sure the correct dose of Biopoin is in the syringe.
Ponovno preverite, ali je v brizgi ustrezen odmerek zdravila Biopoin.
Once hypertension has been controlled with more intensified therapy, epoetin theta therapy should be re-started at a reduced dose.
Ko je hipertenzija ob uporabi intenzivnejšega zdravljenja nadzorovana, je treba zdravljenje z epoetinom theta ponovno uvesti z zmanjšanim odmerkom.
If you think you are having this type of reaction, you must stop your Biopoin injection and get medical help immediately.
Če menite, da imate to vrsto reakcije, morate prenehati injicirati zdravilo Biopoin in takoj poiskati zdravniško pomoč.
Subcutaneous injections should be given into the abdomen, arm or thigh.
Subkutano injiciranje se sme dajati samo v abdomen, roko ali stegno.
Increases in blood pressure may require treatment with antihypertensive medicinal products or a dose increase of existing antihypertensive medicinal products.
Zvišanje krvnega tlaka lahko zahteva zdravljenje z antihipertenzivi ali povečanje odmerka obstoječega antihipertenziva.
Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA01
Farmakoterapevtska skupina: druga zdravila za zdravljenje slabokrvnosti, oznaka ATC: B03XA01 Mehanizem delovanja
In these two studies, 180 haemodialysis patients and 193 patients not undergoing dialysis were switched from maintenance phase treatment with epoetin beta to treatment with epoetin theta for a period of six months showing stable haemoglobin values and a similar safety profile as epoetin beta.
V teh dveh študijah so pri 180 bolnikih na hemodializi in 193 brez dialize vzdrževalno zdravljenje z epoetinom beta za šest mesecev zamenjali z epoetinom theta, kar je pokazalo stabilne vrednosti hemoglobina in podoben varnostni profil kot pri epoetinu beta.
The dose may be increased after 4 weeks to 80 IU/kg, 3 times per week, and by further increases of 25% of the previous dose at monthly intervals, if needed.
Po štirih tednih se lahko odmerek poveča na 80 i.e./kg trikrat na teden, pozneje pa po potrebi za 25 % predhodnega odmerka v mesečnih presledkih.
If signs and symptoms suggestive of these reactions appear, epoetin theta should be withdrawn immediately and an alternative treatment considered.
Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravljenje z epoetinom theta takoj prekiniti in razmisliti o drugi vrsti zdravljenja.
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.
Te študije so pokazale skladno nepojasnjeno statistično pomembno čezmerno umrljivost pri bolnikih, pri katerih je bila anemija povezana z različnimi pogostimi raki in ki so prejemali rekombinantni humani eritropoetin, v primerjavi s kontrolnimi skupinami.
Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow.
Humani eritropoetin je endogeni glikoproteinski hormon, ki je primarni regulator eritrocitopoeze, saj ima posebno interakcijo z receptorjem eritropoetina na eritroidne progenitorne celice v kostnem mozgu.
Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Pri bolnikih s hepatitisom C, zdravljenih z interferonom in ribavarinom, so o teh primerih poročali ob sočasnem zdravljenju z epoetini.
If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Če niste prepričani, da si želite injicirati zdravilo, ali imate kakršna koli vprašanja, se za pomoč obrnite na zdravnika ali medicinsko sestro.
Thromboembolic events
Pogosti trombembolični dogodki
The second study was conducted in 223 patients with various solid tumours receiving platinum-containing chemotherapy.
Drugo študijo so opravili pri 233 bolnikih z različnimi solidnimi tumorji, ki so prejemali kemoterapijo s platino.
If you think you have injected more Biopoin than you should, contact your doctor.
Če menite, da ste si injicirali večji odmerek zdravila Biopoin, kot bi smeli, se obrnite na zdravnika.
Subcutaneous administration: The weekly dose can be given as one injection per week or three times per week.
Subkutana uporaba: tedenski odmerek se lahko daje kot eno injiciranje na teden ali trikrat na teden.
If you have missed an injection, or injected too little, talk to your doctor.
Če ste si pozabili injicirati zdravilo ali ste injicirali premajhen odmerek, se pogovorite z zdravnikom.
Only clear, colourless solutions without particles should be used.
Uporabljajte le bistre, brezbarvne raztopine brez delcev.
With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
Medtem ko je brizga obrnjena navzgor, iz nje iztisnite ves zrak, tako da bat počasi potiskate navzgor.
Box for the prescribed dose Subcutaneous or intravenous use
Škatla za predpisano odmerjanje subkutana ali intravenska uporaba