natgillin/translations-raw huggingface dataset:
Hence, this supports the lower doses proposed for Sandimmun Neoral in the proposed SmPC. 
To kaže na to, da so manjši odmerki, ki so bili v predlaganem povzetku glavnih značilnosti zdravila predlagani za zdravilo Sandimmun Neoral, upravičeni.
A revised wording was proposed by the MAH accordingly and endorsed by the CHMP. 
Imetnik dovoljenja za promet z zdravilom je nato predlagal spremenjeno besedilo, ki ga je CHMP odobril.
The CHMP was of the view that the proposed text is relevant to include and therefore the CHMP agreed with the wordings as proposed by the MAH. 
Ta dva odstavka nista bila vključena v CSP. CHMP je menil, da je vključitev predlaganega besedila smiselna, zato je odobril besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom.
A wording was agreed accordingly. 
Besedilo je bilo ustrezno usklajeno.
All MS except Norway have the indication bone marrow transplantation and GVHD approved. 
Indikacija presaditev kostnega mozga in GVHD je odobrena v vseh državah članicah, razen na Norveškem.
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Sandimmum and associated names (see Annex I). 
je odbor CHMP priporočil spremembo dovoljenj za promet z zdravilom Sandimmun in povezanimi imeni (glejte Prilogo I), za katerega so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo opredeljeni v Prilogi III.
The proposed wording was acceptable to the CHMP. 
CHMP je menil, da je predlagano besedilo sprejemljivo.
” This wording was endorsed by the CHMP. 
CHMP je to besedilo odobril.
The MAH agrees with the CHMP's view. 
CHMP se je strinjal s tem mnenjem.
Section 6.3 - Shelf life 
Poglavje 6.3 - Rok uporabnosti
The MAH accepted the proposal to amend the ADRs as highlighted by the CHMP. 
Imetnik dovoljenja za promet z zdravilom se je strinjal s spremembo podatkov o neželenih učinkih, ki jo je predlagal CHMP.
The MAH proposed to harmonise the SmPC text along with the agreed CSP. 
Imetnik dovoljenja za promet z zdravilom je predlagal, da se besedilo povzetka glavnih značilnosti zdravila uskladi v skladu z odobrenim CSP. CHMP se je s predlaganim besedilom strinjal.
The CHMP therefore agreed with the approach taken by the MAH. 
CHMP se je zato strinjal s pristopom imetnika dovoljenja za promet z zdravilom.
The daily doses of Neoral should always be given in two divided doses.” The MAH's statement “The dose ranges given for oral administration are intended to serve as guidelines only” is endorsed by the CHMP. 
CHMP je odobril stavek imetnika dovoljenja „razpone odmerkov za peroralno uporabo je treba upoštevati zgolj kot smernice“.
The CHMP was in agreement with the approach taken by the MAH. 
CHMP se je strinjal s pristopom imetnika dovoljenja za promet z zdravilom.
This point was addressed by the MAH and a wording was agreed. 
Imetnik dovoljenja za promet je obravnaval ta predlog, nato pa je bilo besedilo usklajeno.
Thus, a wording was proposed by the MAH and agreed by the CHMP to address this matter. 
Imetnik dovoljenja za promet z zdravilom je zato v zvezi s tem predlagal ustrezno besedilo, ki ga je CHMP odobril.
• Bone marrow transplantation 
• Presaditev kostnega mozga
The recommended dose is… 
Priporočeni odmerek je …
It is unlikely to be serious. 
Ni verjetno, da bo šlo za resno težavo.
It needs to be treated at once. 
To je treba zdraviti takoj.
End of 7 days period at room temperature: __/__/____ 
Konec sedemdnevnega obdobja na sobni temperaturi: __/__/____
This can help to provide more information on the safety of medicines like this one. 
To pomaga zagotoviti več informacij o varnosti zdravila, kot je to.
Find a comfortable, well-lit place. 
Pojdite na udobno in dobro osvetljeno mesto.
cannot be estimated from the available data. 
ni mogoče oceniti iz razpoložljivih podatkov.
Please use as follows: 
Uporabljajte na naslednji način:
Proper treatment of your disease, however, requires close and constant co-operation with your doctor. 
Kljub temu pa ustrezno zdravljenje vaše bolezni zahteva pozorno in stalno sodelovanje z zdravnikom.
This medicine may not be suitable for the following patients. 
To zdravilo morda ne bo primerno za naslednje bolnike.
Furthermore, deaths were more frequent in this patient group compared to younger patients. 
Poleg tega so bile smrti v tej skupini pogostejše kot pri mlajših bolnikih.
It acts as a mitosis-stimulating factor and differentiation hormone. 
Deluje kot mitozo stimulirajoči dejavnik in diferenciacijski hormon.
- if you have high blood pressure that cannot be controlled. 
- če imate visok krvni tlak, ki ga ni mogoče nadzorovati.
Even at very high blood levels, no symptoms of poisoning have been observed. 
Celo pri zelo visokih ravneh v krvi niso opazili nobenih simptomov zastrupitve.
b) Maintaining sufficient red blood cell levels 
b) Vzdrževanje zadostnega števila rdečih krvničk
Approximately 9% of patients can be expected to experience an adverse reaction. 
Pri približno 9 % bolnikov se pričakuje, da se bo pojavil neželeni učinek.
These symptoms could indicate that your treatment with this medicine is ineffective. 
Ti simptomi lahko kažejo, da je zdravljenje s tem zdravilom neučinkovito.
Please discuss this with your doctor. 
O tem se pogovorite z zdravnikom.
- Uncontrolled hypertension. 
- nenadzorovana hipertenzija.
Do not warm Biopoin in any other way (for example, do not warm it in a microwave or in hot water). 
Zdravila Biopoin ne grejte na noben drug način (na primer ne segrevajte ga v mikrovalovni pečici ali vroči vodi).
Red blood cells are very important for distributing oxygen within your body. 
Rdeče krvničke so zelo pomembne za porazdelitev kisika v telesu.
Healthy people should not use Biopoin. 
Zdravi ljudje ne smejo uporabljati zdravila Biopoin.
Your healthcare professional will always record the exact product you are using. 
Zdravstveni delavec bo vedno natančno zabeležil, katero zdravilo uporabljate.
Do not give this medicine to children and adolescents under 18 years of age because there are no data that show that this medicine is safe and works in this age group. 
Tega zdravila ne dajajte otrokom in mladostnikom, starim manj kot 18 let, saj ni podatkov o varnosti in učinkovanju zdravila pri tej starostni skupini.
It works in exactly the same way as erythropoietin. 
Deluje popolnoma enako kot eritropoetin.
Your doctor will work out the right dose for you. 
Zdravnik bo določil pravi odmerek za vas.
● Risk Management Plan (RMP) 
ZDRAVILA • Načrt za obvladovanje tveganja (RMP)
Very rare: Not known: 
Zelo redki: Neznana:
The extent of absorption (AUC) was slightly greater after injection in the abdomen in comparison to the other sites. 
Obseg absorpcije (AUC) je bil rahlo večji po injiciranju v abdomen kot na drugih dveh mestih.
It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine. 
Pomembno je, da zdravniku poveste, če ste noseči, menite, da bi lahko bili noseči ali načrtujete nosečnost, saj se lahko odloči, da tega zdravila ne smete uporabljati.
Epoetins are not indicated for use in this patient population. 
Epoetini niso indicirani za uporabo pri tej skupini bolnikov.
The safety of epoetin theta has been evaluated based on results from clinical studies including 972 patients. 
Varnost epoetina theta so ocenili na podlagi rezultatov kliničnih študij, ki so vključile 972 bolnikov.
- Severely elevated blood pressure: 
- Hudo zvišan krvni tlak:
Anaemia occurs when your blood does not contain enough red blood cells. 
Anemija se pojavi, kadar kri ne vsebuje dovolj rdečih krvničk.
It is recommended that haemoglobin be monitored every two weeks until levels have stabilised and periodically thereafter. 
Priporočeno je, da se vrednost hemoglobina spremlja vsaka dva tedna, dokler se ravni ne stabilizirajo, potem pa občasno.
If necessary, your doctor will increase your dose at monthly intervals. 
Po potrebi bo zdravnik odmerek povečeval v mesečnih presledkih.
Date of latest renewal: 26 August 2014. 
Datum prve odobritve: 23. oktober 2009 Datum zadnjega podaljšanja: 26. avgust 2014
The safety and efficacy of Biopoin in children and adolescents aged up to 17 years have not yet been established. 
Pediatrična populacija Varnost in učinkovitost zdravila Biopoin pri otrocih in mladostnikih, starih do 17 let, nista bili dokazani.
The solution should be visually inspected prior to use. 
Pred uporabo je treba raztopino vizualno pregledati.
Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of epoetins and should therefore be corrected. 
Pomanjkanje železa, folne kisline ali vitamina B12 zmanjša učinkovitost epoetinov, zato ga je treba popraviti.
Before you stop using this medicine, talk to your doctor. 
Preden prenehate uporabljati to zdravilo, se pogovorite z zdravnikom.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. 
Receptorji eritropoetina so lahko izraženi na površini različnih tumorskih celic.
For instructions on handling of the medicinal product before administration, see section 6.6. 
Za navodila glede ravnanja z zdravilom pred dajanjem, glejte poglavje 6.6.
Maintenance phase 
Vzdrževalna faza
A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials. 
Opravili so tudi sistematični pregled, ki je vključil več kot 9000 bolnikov z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
- Do not put the cover back on used needles. 
- Pokrovčka ne dajajte nazaj na uporabljene igle.
Your doctor or nurse will give you instructions on how to do this. 
Zdravnik ali medicinska sestra vam bosta dala navodila.
If your iron level is too low, your doctor may also prescribe you an iron preparation. 
Če je raven železa prenizka, vam bo zdravnik morda predpisal tudi pripravek železa.
- if you are allergic to epoetin theta, another epoetin or any of the other ingredients of this medicine (listed in section 6); 
- če ste alergični na epoetin theta, drug epoetin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Biopoin has not been tested in pregnant women. 
Zdravila Biopoin niso preizkusili pri nosečnicah.
Your doctor will carry out regular blood tests in order to monitor various blood components and their levels. 
Zdravnik bo opravil običajne krvne preiskave, da bo spremljal različne krvne elemente in njihove ravni.
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). 
Dejavniki, ki jih je treba pretehtati v tej oceni, morajo vključevati vrsto tumorja in njegov stadij, stopnjo anemije, pričakovano življenjsko dobo, okolje, v katerem se bolnik zdravi, in bolnikovo prednostno izbiro (glejte poglavje 5.1).
The maximum concentration is reached after an average of 10 to 14 hours and the average terminal half-life ranges from approximately 22 to 41 hours. 
Največja koncentracija se v povprečju doseže po 10 do 14 urah, povprečni končni razpolovni čas pa se giba med 22 in 41 ur.
At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions. 
Ko se bolnikom predpiše zdravilo, jim je treba svetovati glede znakov in simptomov ter jih skrbno spremljati glede kožnih reakcij.
Epoetin theta is a protein produced by biotechnology. 
Epoetin theta je beljakovina, ki se izdeluje z biotehnologijo.
These may be signs of severely elevated blood pressure, even if your blood pressure is usually normal or low. 
To so lahko znaki hudo zvišanega krvnega tlaka, tudi če je vaš krvni tlak navadno normalen ali nizek.
Do not remove the needle cover from the syringe until you are ready to inject. 
Pokrovčka za iglo ne odstranite, dokler niste pripravljeni na injiciranje.
It is better to change the injection site every day to avoid the risk of soreness at any one site. 
Najbolje je, da mesto injiciranja menjate vsak dan, da se izognete tveganju bolečine na nekem mestu.
If you are a cancer patient you should be aware that this medicine may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer. 
Če imate raka, morate vedeti, da lahko to zdravilo deluje kot rastni faktor za krvničke in lahko v nekaterih primerih negativno vpliva na raka.
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 je bilo razmerje tveganja za splošno preživetje od 1,25 do 2,47 v korist kontrolnih skupin.
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 drugih treh pa 12-14 g/dl.
This may be associated with life-threatening cardiovascular complications. 
To je lahko povezano s smrtno nevarnimi kardiovaskularnimi zapleti.
Do not use any Biopoin that is left in the syringe. 
Ne uporabite zdravila Biopoin, ki je ostalo v brizgi.
If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to reduce the haemoglobin level. 
Če se pojavi huda policitemija, so lahko indicirane konvencionalne metode (flebotomija) za znižanje ravni hemoglobina.
Epoetin theta has no or negligible influence on the ability to drive and use machines. 
Epoetin theta nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Your doctor will carry out blood tests regularly and adjust the dosage or suspend the treatment if necessary. 
Zdravnik bo redno opravljal krvne preiskave in prilagodil odmerek ali po potrebi prekinil zdravljenje.
Therapy should be continued up to 4 weeks after the end of chemotherapy. 
Zdravljenje je treba nadaljevati do 4 tedne po končani kemoterapiji.
During the studies, mortality was lower in the epoetin theta group (6.9%) compared to placebo (10.3%). 
Med temi študijami je bila umrljivost manjša v skupini, ki je prejemala epoetin theta, (6,9odstotna) kot v skupini, ki je prejemala placebo (10,3-odstotna).
After administration of epoetin theta, the number of erythrocytes, the haematocrit values and reticulocyte counts increase. 
Po uporabi epoetina theta se število eritrocitov, vrednosti hematokrita in število retikulocitov povečajo.
Effect on tumour growth 
Učinek na rast tumorja
To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment. 
Da se zagotovi učinkovita eritrocitopoeza, je treba pri vseh bolnikih pred zdravljenjem in med njim oceniti stanje železa.
Other medicines and Biopoin 
Druga zdravila in zdravilo Biopoin
Hypertension can be treated with appropriate medicinal products (see section 4.4). 
Zdravi se lahko z ustreznimi zdravili (glejte poglavje 4.4).
The initial dose is 20,000 IU. 
Začetni odmerek je 20.000 i.e.
In order to improve the traceability of epoetins, the name of the administered epoetin should be clearly recorded in the patient file. 
Za izboljšanje sledljivosti epoetinov je treba v bolnikovo kartoteko jasno zabeležiti ime uporabljenega epoetina.
Your treatment with this medicine is being initiated by a doctor who is experienced in the above-mentioned indications. 
Zdravljenje s tem zdravilom bo uvedel zdravnik z izkušnjami z zgoraj navedenimi indikacijami.
This is known as a subcutaneous injection. 
To se imenuje subkutano injiciranje.
Particular attention should be paid to sudden sharp migraine-like headaches as a possible warning signal. 
Posebej je treba paziti na pojav nenadnih, zbadajočih glavobolov, podobnih migreni, ki so morebitni opozorilni znak.
Adverse reactions listed below in table 1 are classified according to System Organ Class. 
Navedeni neželeni učinki so razvrščeni v spodnji preglednici 1 glede na organske sisteme.
You will usually receive Biopoin until 1 month after the end of chemotherapy. 
Zdravilo Biopoin boste navadno prejemali do enega meseca po koncu kemoterapije.
If a dose adjustment is required to maintain the desired haemoglobin level, it is recommended that the dose be adjusted by approximately 25%. 
Če je za vzdrževanje želene ravni hemoglobina treba prilagoditi odmerek, se priporoča, da se odmerek prilagodi za približno 25 %.
In clinical trials, patients over 75 years of age had a higher incidence of serious and severe adverse events irrespective of a causal relationship to treatment with epoetin theta. 
V kliničnih preskušanjih so imeli bolniki, starejši od 75 let, večjo incidenco resnih in hudih neželenih dogodkov, ne glede na vzročno povezanost z zdravljenjem z epoetinom theta.
*See subsection “Description of selected adverse reactions” below 
*Glejte spodnje podpoglavje "Opis izbranih neželenih učinkov"
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.