natgillin/translations-raw huggingface dataset:
Dynepo has no or negligible influence on the ability to drive and use machines.
Dynepo nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Dynepo can be given in a very large range of doses.
Dynepo se lahko uporablja v zelo velikem razponu odmerkov.
When administration is halted, the eyrthropoietic parameters return toward baseline levels within the recovery period of 1-3 months.
Po prenehanju uporabe se eritropoetski parametri vrnejo na izhodiščno raven v obdobju okrevanja od 1 do 3 mesecev.
If you see blood in the syringe, remove the needle and put it in another place.
Če v injekcijski brizgi vidite kri, odstranite iglo in jo vbodite na drugem mestu.
B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
If someone else is injecting for you, they can also use the back of your arms.
Če vam zdravilo daje kdo drug, ga lahko injicira tudi na zadnji strani roke.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Receptorji za eritropoetin so lahko izraženi tudi na površini različnih vrst tumorskih celic.
Following intravenous doses, volume of distribution approximates total blood volume and ranges from 0.063 to 0.097 l/kg.
Po intravenski uporabi se volumen distribucije približa celotnemu volumnu krvi in sega od 0,063 do 0,097 l/kg.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
Znotraj vsake skupine so neželeni učinki glede na resnost razvrščeni padajoče:
This is the most common cause of an incomplete response to an erythropoietin therapy.
To je najpogostejši vzrok nezadostnega odziva na zdravljenje z eritropoetinom.
If you accidentally give yourself too large a dose, tell your doctor.
Če si pomotoma daste prevelik odmerek, to povejte zdravniku.
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 8167 patients).
Metaanaliza podatkov o celokupnega preživetja je pokazala točkovno oceno razmerja tveganja 1,08 v prid kontrolnim preiskovancem (95-% IZ: 0,99, 1,18; 42 preskušanj in 8.167 bolnikov).
Half life is approximately 50% shorter in healthy subjects.
Pri zdravih preiskovancih je razpolovni čas približno 50% krajši.
Particular attention should be paid to sudden sharp migraine-like headaches as a possible warning signal.
Posebno pozornost je kot možnemu opozorilnemu znaku treba nameniti nenadnim, močnim, migreni podobnim glavobolom.
Lactation: It is not known whether Dynepo is excreted in human breast milk.
Dojenje: Ni znano, ali se Dynepo izloča v materinem mleku.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvajal študije in dodatne farmakovigilančne dejavnosti, ki so opisane v Farmakovigilančnem načru.
Because of the time required for erythropoiesis, an interval of approximately 4 weeks may occur between the time of a dose adjustment (initiation, increase, decrease or discontinuation) and a significant change in haemoglobin.
Zaradi časa, ki je potreben za eritropoezo, lahko med prilagoditvijo odmerka (začetek, zvečanje, zmanjšanje ali prekinitev) in pomembno spremembo hemoglobina pretečejo približno 4 tedni.
Red blood cells are very important since they contain haemoglobin, a protein which distributes oxygen in your body.
Rdeče krvne celice so zelo pomembne, ker vsebujejo beljakovino hemoglobin, ki prenaša kisik po telesu.
Dynepo may not be suitable for patients under 18 years old, or for patients with renal or liver problems.
Dynepo utegne biti neprimeren za bolnike, mlajše od 18 let, in za bolnike, ki imajo težave z ledvicami
It may also be necessary to reduce your dose of Dynepo or to stop the treatment for a short period of time.
Morda bo treba tudi zmanjšati odmerek Dynepa ali za krajši čas prekiniti zdravljenje z njim.
The target haemoglobin concentration in two studies was >13 g/dL; in the remaining three studies it was 12-14 g/dL.
Ciljna koncentracija hemoglobina v dveh študijah je bila >13 g/dl, v ostalih treh pa 12-14 g/dL.
No special dosage adjustments are required in elderly patients.
Pri starejših bolnikih odmerka ni treba posebej prilagajati.
The maximum dose of epoetin delta that can be safely administered in single or multiple doses has not been determined.
Največji odmerek epoetina delta, ki ga je mogoče varno uporabiti v posamičnem ali več odmerkih, ni
The biological efficacy of erythropoietin has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (rats and dogs).
Biološka učinkovitost eritropoetina po intravenski in subkutani uporabi je in vivo dokazana na različnih živalskih modelih (podgane in psi).
Most of patients with chronic renal failure have a history of hypertension.
Večina bolnikov s kronično odpovedjo ledvic ima anamnezo hipertenzije.
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 in posledice anemije se lahko razlikujejo glede na starost, spol in celotno breme bolezni, zato je zdravnikova ocena kliničnega poteka bolezni in splošnega stanja posameznega bolnika nujna.
The most frequent side effects observed (in 1% to 10% of patients) with Dynepo are: - increase in blood pressure.
Najpogostejši neželeni učinki, (opaženi pri 1% do 10% bolnikov) pri uporabi zdravila Dynepo so: - Zvišanje krvnega tlaka.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA)
It may not be necessary to use erythropoietin during the first three months after starting peritoneal dialysis because an increase in haemoglobin often occurs during this period.
Zgodi se lahko, da eritropoetina v prvih treh mesecih po začetku peritonealne dialize ni treba uporabljati, ker hemoglobin med tem obdobjem pogosto poraste.
Virtually all patients will eventually require supplemental iron to increase or maintain transferrin saturation and ferritin to levels that will adequately support erythropoiesis stimulated by Dynepo.
Skoraj vsi bolniki bodo lahko potrebovali dodatno železo za zvečanje ali ohranitev nasičenosti transferina in koncentracije feritina na ravni, potrebni za ustrezno eritropoezo, ki jo spodbudi Dynepo.
Two of the studies recruited patients who were being treated with chemotherapy.
V dve študiji so vključili bolnike, ki se prejemali kemoterapijo.
If it occurs, appropriate dose adjustment should be made as provided.
Če do tega pride, je treba prilagoditi odmerjanje, kakor je opisano v nadaljevanju.
Your doctor will probably not make changes to your dosage more than once a month.
Zdravnik odmerka verjetno ne bo spreminjal pogosteje kot enkrat na mesec.
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.
Kontrolirana klinična preskušanja niso pokazala pomembnih koristi, ki bi jih pripisali dajanju epoetinov, če so ravni hemoglobina povečane nad raven, ki je potrebna za kontrolo simptomov anemije in izognitev transfuzijam krvi.
It could be a consequence of a marked rise in your blood pressure.
Lahko gre za posledico močno zvišanega krvnega tlaka.
WHAT DYNEPO IS AND WHAT IT IS USED FOR
KAJ JE DYNEPO IN ZA KAJ GA UPORABLJAMO
Dynepo therapy is usually a long-term treatment.
Zdravljenje z Dynepom je ponavadi dolgoročno.
You will need to give yourself an injection into the tissue under the skin, known as a subcutaneous injection.
Dvakrat na teden si boste morali dati injekcijo v tkivo pod kožo, kar je znano kot subkutano injiciranje.
Do not remove the cover from the syringe until you are ready to inject.
Ne odstranite pokrovčka na injekcijski brizgi preden ste pripravljeni za injiciranje.
Your doctor will manage your dosage so that haemoglobin concentrations will not consistently be above 12 g/dl which may be associated with a higher risk of cardiovascular events (e.g. heart attacks).
Vaš zdravnik bo prilagodil odmerjanje tako, da ravni hemoglobina ne bodo stalno nad 12 g/dl, kar je lahko povezano z večjim tveganjem srčno-žilnih dogodkov (npr. srčnega infarkta).
For information on how to inject Dynepo yourself, please read the instructions at the end of this leaflet.
Za podatke o tem, kako si lahko sami injicirate zdravilo Dynepo, si preberite navodila na koncu teh
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in Section 4.2.
Pri bolnikih s kronično ledvično odpovedjo vzdrževana raven hemoglobina ne sme preseči zgornje meje ciljnega razpona koncentracij hemoglobina, ki so priporočene v poglavju 4.2.
Berkshire SL1 4DX United Kingdom
Berkshire SL1 4DX Velika Britanija
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in you hand for a few minutes.
Da si boste zdravilo lažje vbrizgali, pustite injekcijsko brizgo stati 30 minut na sobni temperaturi ali pa napolnjeno injekcijsko brizgo nekaj minut rahlo držite v roki.
If you have severe headache, stabbing migraine-like headaches or fits, you should see your doctor at once.
Če doživite močan glavobol, oster migrenski glavobol ali napad krčev, morate nemudoma k zdravniku.
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.
V kakšni meri ti rezultati veljajo za dajanje rekombinantnega humanega eritropoetina bolnikom z rakom na kemoterapiji za doseganje ravni hemoglobina pod 13 g/dl ni jasno, saj so v ta pregled podatkov vključili malo takšnih bolnikov.
• The abdomen, except for the area around the naval.
• trebuh, razen predelov okoli popka.
After any change to the dose, you will have frequent blood tests (once a week) until your haemoglobin level reaches the target range.
Po vsaki spremembi odmerka boste pogosto (enkrat na teden) opravili preiskavo krvi, dokler koncentracija hemoglobina ne doseže ciljnega območja.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, Doslej med zdravljenjem z Dynepom ni bilo opisanih medsebojnih delovanj z drugimi zdravili.
- If you have any further questions, ask your doctor or pharmacist.
- Če imate kakršna koli dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
If the suggested target range is exceeded, treatment with epoetin delta should be temporarily withdrawn until the haemoglobin/haematocrit returns to the suggested target range.
Če je priporočeno ciljno območje preseženo, je treba zdravljenje z epoetinom delta začasno prekiniti, dokler se hemoglobin oz. hematokrit ne vrneta v priporočeno ciljno območje.
Epoetin delta can then be reintroduced with a lower dosage (see section 4.2).
Potem je mogoče zdravljenje začeti znova, z manjšim odmerkom (glejte poglavje 4.2).
Your dose of Dynepo will be determined by your doctor and will be adjusted individually according to your personal needs.
Zdravnik bo določil odmerek Dynepa in ga individualno prilagodil vašim osebnim potrebam.
Anaemia in epoetin-resistant or hyporesponsive patients with failure to respond to 20,000 IU/week should be investigated, including referral to a haematologist.
Anemijo pri bolnikih, ki so na epoetin odporni ali premalo odzivni ter se ne odzovejo na 20.000 i.e./teden, je treba raziskati in jih napotiti k hematologu.
The most common are hypertension, access related thrombosis and headache.
Najpogostejši med njimi so zvišan krvni tlak, z dostopom povezana tromboza in glavobol.
Only use each syringe for one injection.
Vsako injekcijsko brizgo uporabite samo enkrat.
During Dynepo therapy, absolute or functional iron deficiency may develop.
Med zdravljenjem z Dynepom se lahko pojavi absolutno ali funkcijsko pomanjkanje železa.
Dynepo may be administered intravenously (into a vein) or subcutaneously (under the skin).
Dynepo se lahko daje intravensko (v veno) ali subkutano (pod kožo).
The pharmacokinetics of erythropoietin following administration of epoetin delta has been examined in both healthy volunteers and patients with chronic renal failure.
Farmakokinetiko eritropoetina po uporabi epoetina delta so raziskali pri zdravih prostovoljcih in bolnikih s kronično odpovedjo ledvic.
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 March 2002
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 18. marec 2002
In patients not on haemodialysis, where intravenous access is not readily available, Dynepo is usually given subcutaneously.
Bolniki, ki niso na hemodializi, in pri katerih intravenski dostop ni pripravljen, Dynepo ponavadi dobivajo subkutano.
Do not touch the needle or push the
Ne dotikate se igle in ne potiskajte bata.
Driving and using machines No effects on ability to drive and use machines have been observed.
Vpliv na sposobnost upravljanja vozil in strojev Niso opaženi nobeni učinki na sposobnost vožnje in upravljanja s stroji.
This may be associated with life-threatening cardiovascular complications.
Posledica so lahko smrtno nevarni kardiovaskularni zapleti.
You can now use the pre-filled syringe.
Sedaj lahko uporabite napolnjeno injekcijsko brizgo.
In consequence, dose adjustment should not be made more frequently than once a month, unless clinically indicated.
Zato se odmerka ne sme prilagajati pogosteje kot enkrat na mesec, razen če je
Dynepo is used for treating the symptoms of anaemia (which include tiredness, weakness and shortness of breath) associated with chronic renal failure in adult patients, Anaemia is a blood disorder characterised by a decrease in red blood cells.
Dynepo se uporablja za zdravljenje simptomov anemije (ki vključujejo utrujenost, oslabljenost in zasoplost), ki je povezana s kronično ledvično odpovedjo pri odraslih bolnikih.Anemija je bolezen krvi, za katero je značilno zmanjšanje števila rdečih krvnih celic.
The haemoglobin level should then be monitored at regular intervals.
Potem je treba koncentracijo hemoglobina kontrolirati v rednih presledkih.
Dynepo contains less than 1mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".
Zdravilo Dynepo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar praktično pomeni, da »ne
Your doctor will be experienced in the treatment of renal failure and the use of erythropoietin.
Vaš zdravnik ima izkušnje z zdravljenjem odpovedi ledvic in uporabo eritropoetina.
Put the needle fully into the skin as shown by your nurse or doctor.
Vbodite iglo v kožo, kot sta vam pokazala zdravnik ali medicinska sestra.
Check that it is the correct dose that your doctor has prescribed.
Preverite, če injekcijska brizga vsebuje pravilen odmerek zdravila, kot ga je predpisal zdravnik.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Pri nekliničnih študijah je bilo negativne učinke moč zaznati samo pri odmerkih, ki so bili neprimerljivo višji od največje izpostavljenosti pri človeku, kar kaže na majhen pomen za klinično uporabo.
България / Česká Republika/ Danmark/ Eesti/ Ελλάδα/ Ireland/ Ísland/ Κύπρος/ Latvija/ Lietuva/ Magyarország/ Malta/ Nederland/ Norge/ Österreich/Polska/ România/ Slovenija/ Slovenská Republika/ Suomi/ Sverige/United Kingdom
България /Česká Republika/ Danmark/ Eesti/ Ελλάδα/ Ireland/ Ísland/ Κύπρος/ Latvija/
Your doctor may decide that it would be best for you to inject Dynepo yourself.
Vaš osebni zdravnik se lahko odloči, da bi bilo za vas najbolje, če si sami injicirate zdravilo.
During dialysis, an increase in the dose of the anticoagulation treatment is frequently required since the increased number of red blood cells may cause blocking of the dialysis tubes.
Med dializo je pogosto treba zvečati odmerek antikoagulantnih zdravil, ker lahko zvečano število rdečih krvnih celic povzroči zamašitev dializnih cevk.
The bioavailability of subcutaneously administered epoetin delta is between 26% and 36%.
Biološka uporabnost subkutano uporabljenega epoetina delta je med 26%
If transferrin saturation falls below 20 %, or if ferritin falls below 100 ng/ml, iron should be administered.
Če se nasičenost transferina zniža pod 20% ali koncentracija feritina upade pod 100 ng/ml, je treba dati železo.
Misuse of epoetin by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
Zloraba epoetina pri zdravih osebah lahko čezmerno zviša hemoglobin in hematokrit.
The half-life of subcutaneously administered epoetin delta is prolonged compared to intravenous administration and ranges from 27 to 33 hours in patients.
Razpolovni čas subkutano uporabljenega epoetina delta je daljši kot po intravenski uporabi in znaša pri bolnikih od 27 do 33 ur.
Take your Dynepo pre-filled syringe out of the refrigerator.
Z zdravilom Dynepo napolnjeno injekcijsko brizgo vzemite iz hladilnika.
If your blood pressure rises, your doctor may give you medicines to reduce your blood pressure or increase the dosage of your existing blood pressure lowering medication.
Če se krvni tlak zviša, vam bo zdravnik morda predpisal zdravila za znižanje krvnega tlaka ali zvečal odmerek takšnih zdravil, ki jih že jemljete.
Transferrin saturation should be at least 20 %, and ferritin should be at least 100 ng/ml.
Nasičenost transferina mora biti vsaj 20% in koncentracija feritina vsaj 100 ng/ml.
Inspect the pre-filled syringe before use.
Napolnjeno injekcijsko brizgo pred uporabo preglejte.
Therefore, prior to and during Dynepo therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated.
Zato je treba pred zdravljenjem z Dynepom in med samim zdravljenjem določati bolnikove zaloge železa, vključno z nasičenostjo transferina in feritinom v serumu.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Zaradi variabilnosti med bolniki se lahko pri posameznih bolnikih občasno pojavijo vrednosti hemoglobina nad ali pod želeno vrednostjo.
Prolonged vigorous shaking may denature the active substance.
Dolgotrajno močno stresanje lahko denaturira učinkovino.
Increases in blood pressure may require treatment with anti-hypertensive medicines or dosing increase of existing anti-hypertensive medications.
Zaradi zvišanja krvnega tlaka utegne biti potrebno zdravljenje z antihipertenzivnimi zdravili ali zvečanje odmerka že uporabljanih antihipertenzivnih zdravil.
It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Uporabite jo lahko le, če je raztopina v njej bistra, brezbarvna, ne vsebuje vidnih trdnih delcev in ima gostoto, podobno vodi.
The use of Dynepo in nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
Pri bolnikih z nefrosklerozo, ki se še ne zdravijo z dializo, je treba uporabo Dynepa pretehtati posamezno, ker ni mogoče z gotovostjo izključiti možne pospešitve napredovanja odpovedi ledvic.
• Vitamin deficiencies, i.e., folic acid or vitamin B12 deficiencies
• pomanjkanje vitaminov, tj. pomanjkanje folne kisline ali vitamina B12
Other side effects that occur less frequently (in 0.1% to 1% of patients) include itching, pain, reaction at the site of injection (such as soreness and bleeding), flu-syndrome, diarrhoea, nausea.
Med drugimi, redkejšimi (opaženi pri 0,1% do 1% bolnikov) neželenimi učinki so srbenje, bolečine, reakcije na mestu injiciranja (npr. bolečine in krvavitev), gripi podoben sindrom, driska in slabost v želodcu.
Erythropoietin is a growth factor that primarily stimulates red cell production.
Eritropoetin je rastni dejavnik, ki primarno spodbuja nastajanje rdečih krvnih celic.
• Malignant diseases including multiple myeloma and myelodysplastic syndrome
• maligne bolezni, vključno z multiplim mielomom in mielodisplastičnim sindromom
Dynepo may be administered intravenously or subcutaneously.
Dynepo se lahko uporablja intravensko ali subkutano.
If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Due to limited experience, the efficacy and safety of Dynepo could not be assessed in patients with impaired liver function.
Zaradi omejenih izkušenj učinkovitosti in varnosti Dynepa ni mogoče oceniti pri bolnikih z
Dynepo may be used in patients on dialysis (a blood clearance technique) or in patients not on dialysis.
Dynepo se lahko uporablja pri bolnikih, ki so na dializi (postopek za čiščenje krvi), in pri tistih, ki niso.
Even patients with normal blood pressure may have a marked rise in their blood pressure and existing high blood pressure can get worse (See 2.
Celo bolnikom z normalnim krvnim tlakom se lahko krvni tlak izrazito zviša, obstoječ visok krvni tlak pa se lahko poslabša (glejte poglavje 2, Kaj morate vedeti, preden boste uporabili Dynepo).
For subcutaneous injection, the whole length of the needle should be inserted perpendicularly into a skin fold held between thumb and forefinger, the skin fold should be held throughout the injection.
Pri subkutani uporabi je treba v kožno gubo, ki se jo naredi s palcem in kazalcem, navpično vbosti celotno dolžino igle, kožno gubo pa je treba držati med celotnim postopkom injeciranja.
Clean your skin and then pinch the skin between your thumb and forefinger, without squeezing it.
Očistite kožo in s palcem in kazalcem napravite kožno gubo, ne da bi kožo pri tem stiskali.
After injecting the liquid, remove the needle and let go of your skin.
Po končanem injiciranju odstranite iglo in spustite kožno gubo.
Dynepo should not be used by healthy persons.
Zdrave osebe ne smejo uporabljati Dynepa.
Mainly because of the time required for the production of new red blood cells, an interval of approximately 4 weeks may occur between the dose and an improvement in your anaemia.
Zlasti zaradi časa, potrebnega za nastanek novih eritrocitov, lahko od odmerka do izboljšanja anemije minejo približno 4 tedni.
Like all medicines, Dynepo can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Dynepo neželene učinke, ki pa se ne pojavijo pri vseh
An updated Risk Management Plan should be provided as per CHMP Guideline on Risk Management Systems for medicinal products for human use except that routine updates of the Risk Management Plan should be provided yearly until the start of the three-yearly PSUR cycle.
Do začetka 3-letnega cikla oddajanja PSUR-ov je treba letno predložiti dopolnjen Načrt upravljanja tveganja v skladu s Smernicami za sisteme upravljanja tveganja pri zdravilih za uporabo v humani medicini Odbora za zdravila za uporabo v humani medicini (CHMP).
When given subcutaneously, the site of injection should be changed with each injection.
Pri subkutani uporabi je treba injekcijsko mesto za vsako injiciranje izmenično menjati.
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost na zdravilno učinkovino ali na katerokoli pomožno snov.