natgillin/translations-raw huggingface dataset:
Further information on the HMPC assessment of arctic root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o oceni zdravil, ki vsebujejo rožni koren, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
Other information about arctic root medicines
Druge informacije o zdravilih, ki vsebujejo rožni koren
The HMPC conclusions on the use of arctic root medicines are based on their ‘traditional use'.
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo rožni koren, temeljijo na njihovi „tradicionalni uporabi“.
What evidence supports the use of arctic root medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo rožni koren?
Detailed instruction on how to take arctic root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o jemanju zdravil, ki vsebujejo rožni koren, in o tem, kdo jih lahko jemlje, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
Herbal medicines containing arctic root are usually available in solid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo rožni koren, so navadno na voljo v trdnih oblikah, ki se jemljejo peroralno (zaužijejo skozi usta).
What are the risks associated with arctic root medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo rožni koren?
EMA/HMPC/289537/2012
EMA/HMPC/289537/2012 Odbor za zdravila rastlinskega izvora (HMPC)
For more information about treatment with arctic root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo rožni koren, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using arctic root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
Arctic root medicines are generally well tolerated.
Zdravila, ki vsebujejo rožni koren, bolniki običajno dobro prenašajo.
Therefore, the HMPC conclusions on the use of arctic root medicines are based on their long-standing use.
Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo rožni koren, zato temeljijo na njihovi dolgotrajni uporabi.
This usually takes between 15 and 30 minutes.
To običajno traja 15 do 30 minut.
Date of first authorisation: 28 August 2007 Date of latest renewal: 18 June 2012
Datum prve odobritve: 28 avgust 2007 Datum zadnjega podaljšanja: 18 junij 2012
At the final analysis, 1653 deaths were reported.
V končni analizi so poročali o 1.653 smrtnih primerih.
The symptoms are:
Simptomi so:
Do not use this medicine if you notice that
Ne uporabljajte tega zdravila, če opazite
It may affect other treatments or test results.
Vpliva lahko na druga zdravljenja ali rezultate preiskav.
Thus, the volume of distribution is slightly greater than the plasma space.
Zato je volumen porazdelitve nekoliko večji kot plazemski prostor.
Long-term carcinogenicity studies have not been carried out.
Dolgotrajne raziskave karcinogenosti zdravila niso bile opravljene.
Administer the amount required.
Uporabite potrebno količino.
• anaemia from other causes;
• anemijo zaradi drugih razlogov,
Total (N)b
Skupaj (N)b
• Or under the skin (subcutaneously).
• ali pod kožo (subkutano).
Adverse Reaction (Preferred Term Level)
Neželeni učinek (raven prednostnega izraza)
• if you are pregnant, or think you may be pregnant.
• če ste noseči ali menite, da bi lahko bili noseči, • če dojite.
If the medicinal product has not been used at the end of this period, it should be disposed of.
Če zdravila do konca tega obdobja ne porabite, ga je treba zavreči.
• Severe allergic reaction that may include:
• Huda alergijska reakcija, ki lahko vključuje:
• Allergic reaction.
• Alergijska reakcija.
- Uncontrolled hypertension.
- Nenadzorovana hipertenzija.
Adults donating their own blood
Odrasli bolniki, ki darujejo lastno kri
For subcutaneous and intravenous use.
Za subkutano in intravensko uporabo.
After approximately two months of therapy, virtually all patients were transfusion-independent.
Po približno dveh mesecih zdravljenja so bili praktično vsi bolniki neodvisni od transfuzije.
This does not affect normal operation of the syringe.
To na normalno uporabo brizge ne vpliva.
Your doctor will decide if it is right for you to take them.
Vaš zdravnik se bo odločil, ali je za vas dobro, da jih jemljete.
• have severe heart disease
• imate hudo srčno bolezen
• porphyria (a rare blood disorder).
• porfirijo (redko krvno bolezen).
Administer the dose as per standard protocol.
Odmerek aplicirajte po standardnem protokolu.
Administer over at least one to five minutes, depending on the total dose.
Dajanje naj traja vsaj eno do pet minut, odvisno od velikosti skupnega odmerka.
As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Kot pri vseh rastnih dejavnikih tudi tu obstaja skrb, da bi epoetini lahko spodbujali rast tumorjev.
• if you have high blood pressure not properly controlled with medicines.
• če imate zvišan krvni tlak, ki ni ustrezno nadzorovan z zdravili
EPO is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors.
EPO sodeluje v vseh fazah eritroidnega razvoja in ima svoj glavni učinek na raven eritroidnih prekurzorjev.
The cause of your anaemia is also a factor in your doctor deciding the correct dose.
Tudi vzrok vaše anemije je dejavnik, ki ga bo zdravnik upošteval pri določitvi pravilnega odmerka.
It is recommended that initial erythroid response be assessed 8 to 12 weeks following initiation of treatment.
Priporočljivo je, da se začetni eritroidni odziv oceni 8 do 12 tednov po začetku zdravljenja.
This requires urgent treatment.
Tako stanje je treba takoj zdraviti.
• Skin rashes, which may result from an allergic reaction.
• Kožni izpuščaj, ki je lahko posledica alergijske reakcije.
If you know you suffer, or have suffered, from:
Če veste, da imate ali ste imeli:
• Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria).
• Težave s krvjo, ki lahko povzročajo bolečino, temno obarvan urin ali povečano občutljivost kože na sončno svetlobo (porfirija).
As with any other injectable product, check that there are no particles in the solution or change in colour.
Kot pri vseh drugih zdravilih, ki se injicirajo, je treba preveriti, da v raztopini ni delcev ali da barva ni spremenjena.
Currently available data for subcutaneous use of epoetin alfa in these populations are described in section 5.1 but no recommendation on posology can be made.
Trenutno razpoložljivi podatki za subkutano uporabo epoetina alfa pri teh populacijah so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
The median age of patients enrolled in the study was 11.6 years (range 0.5 to 20.1 years).
Mediana starost bolnikov, vključenih v študijo, je bila 11,6 let (razpon med 0,5 in 20,1 let).
Three were confirmed TVE and in the remaining case (sudden death), the thromboembolic event was not confirmed.
Potrjeni so bili trije TVE, v zadnjem primeru (nenadna smrt) pa trombembolični dogodek ni bil potrjen.
• the liquid is coloured or you can see particles floating in it,
• da je tekočina obarvana ali v njej vidite plavati delce,
Your doctor will decide this.
To bo odločil vaš zdravnik.
Raised blood pressure may require treatment with medicines (or adjustment to any medicines you already take for high blood pressure).
Zvišan krvni tlak bo morda treba zdraviti z zdravili (ali prilagoditi zdravilo, ki ga za visok krvni tlak že jemljete).
Haemoglobin levels should be monitored regularly.
Ravni hemoglobina je treba redno nadzirati.
A study of 7 preterm very low birth weight neonates and 10 healthy adults given i.v.
Študija s 7 novorojenci z zelo nizko porodno telesno maso in 10 zdravimi odraslimi, ki so prejemali i.v.
The pharmacokinetic profile of epoetin alfa in children and adolescents appears to be similar to that of adults.
Kaže, da je farmakokinetični profil epoetina alfa pri otrocih in mladostnikih podoben kot pri odraslih.
This temperature range should be closely maintained until administration to the patient.
Ta temperaturni razpon je treba natančno ohranjati do apliciranja zdravila bolniku.
Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults.
Otroci s telesno maso, manjšo od 30 kg, potrebujejo večje vzdrževalne odmerke kot otroci, ki so težji od 30 kg, in odrasli.
Additional supportive care should be provided as necessary.
Če je potrebno, zagotovimo dodatno podporno zdravljenje.
Your healthcare professional will always record the exact product you are using.
Vaš zdravnik bo vedno natančno zabeležil, katero zdravilo uporabljate.
If you have these symptoms during injection into the vein, a slower delivery of the injection may help to avoid them in the future.
Če te simptome opazite med injiciranjem v veno, jih lahko počasnejše dovajanje zdravila v prihodnje morda prepreči.
Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4).
Potrebno je nadzirati krvni tlak, še zlasti na začetku zdravljenja (glejte poglavje 4.4).
Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Zdravnik bo uporabil najnižji učinkoviti odmerek za nadzor simptomov vaše anemije.
• Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP.
Tell your doctor or nurse immediately if you notice any of the effects in this list.
Zdravniku ali medicinski sestri takoj povejte, če opazite učinke, navedene na tem seznamu.
A less defined profile was observed for RBCs and haemoglobin.
Manj definiran profil so opazili za RKC in hemoglobin.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
Dejanska molekulska masa eritropoetina je od 32.000 do 40.000 daltonov.
• if you are allergic to epoetin alfa or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na epoetin alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
Treatment with Epoetin alfa HEXAL is divided into two stages - correction and maintenance phase.
Zdravljenje z zdravilom Epoetin alfa HEXAL poteka v dveh fazah - korekcijska in vzdrževalna faza.
Corresponding Presentations in Quantity/Volume for each Strength
Ustrezno pakiranje po količini/prostornini za vsako jakost
Target Hb
Ciljna koncentracija Hb
erythropoietin suggested that distribution volume was approximately 1.5 to 2 times higher in the preterm neonates than in the healthy adults, and clearance was approximately 3 times higher in the preterm neonates than in healthy adults.
eritropoetin, kaže, da je bil volumen porazdelitve približno 1,5- do 2-krat večji pri novorojencih kot pri zdravih odraslih, očistek pa približno 3-krat večji pri novorojencih kot pri zdravih odraslih.
Patients should only be switched from one ESA to another under appropriate supervision.
Prehod z enega ESA na drugega mora potekati pod nadzorom.
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 (na primer, če ste v preteklosti imeli krvni strdek, če ste pretežki, imate sladkorno bolezen, bolezen srca ali dalj časa ne morete vstati zaradi kirurškega posega ali bolezni).
Depending on your individual situation a blood transfusion may be preferable.
Glede na vašo osebno stanje bo morda bolje uporabiti transfuzijo krvi.
If you are within a day of your next injection, forget the missed one and carry on with your normal schedule.
Če je naslednji odmerek že čez en dan, izpustite pozabljeni odmerek in nadaljujte z običajnim režimom.
Overall, these studies have methodological limitations but treatment was associated with positive trends towards higher haemoglobin levels.
Te študije so bile na splošno metodološko omejene, vendar je bilo zdravljenje povezano s pozitivnimi trendi pri večji ravni koncentracije hemoglobina.
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 posebne previdnostne ukrepe, povezane z avtolognimi preddonorskimi programi, zlasti rutinsko nadomeščanje tekočine.
< 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
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 57 % bolnikov, ki so prejemali mediani odmerek 200 i.e./kg/teden.
3x/week for 4 weeks
3-krat na teden 4 tedne
In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name and the batch number of the administered ESA should be clearly recorded (or stated) in the patient file.
Zaradi izboljšanja sledljivosti zdravil za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent) je treba ime in številko serije apliciranega ESA jasno zapisati (ali navesti) v bolnikovi kartoteki.
- Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
- Bolniki, naročeni na kirurški poseg, ki zaradi kakršnega koli razloga ne morejo prejemati ustrezne antiagregacijske profilakse.
8.4 micrograms 16.8 micrograms
8,4 mikrogramov 16,8 mikrogramov
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 kontroliranih študijah je bilo razmerje ogroženosti za celokupno preživetje med 1,25 in 2,47 v korist kontrolne skupine.
The haemoglobin response varies between patients and may be impacted by iron stores and the presence of concurrent medical problems.
Odziv na hemoglobin se med bolniki razlikuje, nanj pa lahko vplivajo zaloge železa in prisotnost sočasnih zdravstvenih težav.
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 upoštevati v tej oceni, morajo vključevati vrsto tumorja in stadij bolezni, stopnjo anemije, pričakovano življenjsko dobo, okolje, v katerem se bolnik zdravi, in bolnikove želje (glejte poglavje 5.1).
It is important to tell your doctor if any of the following apply to you.
Pomembno je, da svojemu zdravniku poveste, če kar koli od navedenega velja za vas.
Consequently, epoetin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Posledično se lahko epoetin alfa med nosečnostjo uporablja le, če je pričakovana korist večja od tveganja za plod.
Eighty-one percent of patients achieved the haemoglobin concentration level.
Enainosemdeset odstotkov bolnikov je doseglo želeno raven koncentracije hemoglobina.
In all patients receiving epoetin alfa, blood pressure should be closely monitored and controlled as necessary.
Pri vseh bolnikih, ki prejemajo epoetin alfa, moramo po potrebi skrbno spremljati in nadzorovati krvni tlak.
The median time to target was 11 weeks and the median dose at target was 150 IU/kg/week.
Mediani čas do cilja je bil 11 tednov in mediani odmerek na cilju je bil 150 i.e./kg/teden.
• 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 naročil redne krvne preiskave, da oceni odziv anemije na zdravljenje, in po potrebi odmerek prilagodil, običajno ne pogosteje kot vsake štiri tedne.
Dose increases and decreases should be done one dosing step at a time (see diagram below).
Odmerek je treba povečevati ali zmanjševati po en odmerni korak naenkrat (glejte spodnjo shemo).
Epoetin alfa HEXAL should not be used and discarded - if the liquid is coloured or you can see particles floating in it, - if the seal is broken, - if you know, or think that it may have been accidentally frozen, or - if there has been a refrigerator failure.
Zdravila Epoetin alfa HEXAL se ne sme uporabiti in ga je treba zavreči: - če je tekočina obarvana ali v njej vidite plavati delce, - če je tesnilo poškodovano, - če veste ali mislite, da je bila raztopina pomotoma zamrznjena ali - če hladilnik ni pravilno deloval.
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 svoje površinske celične receptorje, aktivira poti prenosa signalov, ki motijo apoptozo in spodbujajo proliferacijo eritroidnih celic.
It may be necessary to add or increase anti-hypertensive treatment.
Morda bo potrebno dodajanje ali zvečanje odmerka antihipertenziva.
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 markerji povečevali linearno z odmerkom, največji odziv je bil dosežen ob največjih ravneh odmerka.
The role of ESAs on tumour progression or reduced progression-free survival cannot be excluded.
Vloge ESA na napredovanje tumorja ali zmanjšanje preživetja brez napredovanja ni mogoče izključiti.
≤ 2 RBC Units >2 and ≤4 RBC Units >4 RBC Units
≤ 2 enoti RKC > 2 in ≤ 4 enote RKC > 4 enote RKC
• Ensure that you only inject the amount of liquid as instructed by your doctor or nurse.
• Prepričajte se, da si injicirate le količino tekočine po navodilih svojega zdravnika ali medicinske sestre.
• Once your anaemia has been corrected, your doctor will continue to check your blood regularly.
• Ko se anemija popravi, bo zdravnik še naprej odrejal redne preiskave krvi.
25, D-83607 Holzkirchen, Germany
25, D-83607 Holzkirchen, Nemčija
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 vzdrževalni učinek.
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 tumorja so raziskovali v petih velikih nadzorovanih študijah, v katerih je sodelovalo skupno 2.833 bolnikov, med katerimi so bile štiri študije dvojno slepe in nadzorovane s placebom, ena pa je bila odprta.
The pre-filled syringes are ready to use (see section 4.2).
Napolnjene injekcijske brizge so pripravljene za uporabo (glejte poglavje 4.2).
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 zgoraj navedene podatke je v nekaterih kliničnih situacijah transfuzija krvi prednostno zdravljenje za obravnavanje anemije pri bolnikih z rakom.
The first evidence of a response to epoetin alfa is an increase in the reticulocyte count within 10 days, followed by increases in the red cell count, haemoglobin and haematocrit, usually within 2 to 6 weeks.
Prvi dokaz za odziv na epoetin alfa je povečanje števila retikulocitov v 10 dneh, ki mu sledijo povečanja števila rdečih krvnih celic, hemoglobina in hematokrita, običajno v 2 do 6 tednih.
Epoetin alfa HEXAL has no or negligible influence on the ability to drive and use machines.
Zdravilo Epoetin alfa HEXAL nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Medicinal products that decrease erythropoiesis may decrease the response to epoetin alfa.
Zdravila, ki zmanjšujejo eritropoezo, lahko zmanjšajo odziv na epoetin alfa.
• 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:
• 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 nastajanja rdečih krvnih celic (da lahko zdravnik vzame več vaše krvi), če med operacijo ali po njej ne morete prejeti transfuzije lastne krvi.
Extending dose intervals may require an increase in dose.
Pri podaljšanju intervalov odmerjanja bo morda potrebno povečanje odmerka.
• Feeling sick in your stomach
• Občutek slabosti v želodcu
Cases have also been reported in patients with hepatitis C treated with interferon and ribavirin, when ESAs are used concomitantly.
Poročali so o primerih bolnikov s hepatitisom C, zdravljenih z interferonom in ribavirinom s sočasno uporabo ESA.
Two subjects had significant risk factors (atrial fibrillation, heart failure and thrombophlebitis).
Pri dveh osebah so bili prisotni pomembni dejavniki tveganja (atrijska fibrilacija, srčno popuščanje in tromboflebitis).
It is unknown whether exogenous epoetin alfa is excreted in human milk.
Ni znano, ali se eksogeni epoetin alfa izloča v materino mleko.
Adverse drug reactions reported by ≥ 1% of subjects treated with epoetin alfa in these trials are shown in the table below.
Neželeni učinki zdravila, o katerih je poročalo ≥ 1 % oseb, zdravljenih z epoetinom alfa v teh študijah, so prikazani v spodnji preglednici.
Frequency estimate: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to
Ocena pogostnosti: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100);
Clinical data with subcutaneous administration in children are limited.
Klinični podatki s subkutanim dajanjem pri otrocih so omejeni.
Mean haemoglobin levels were similar for the two treatment groups throughout the postsurgical period.
Povprečne ravni hemoglobina so bile podobne za obe skupini zdravljenja ves čas obdobja po kirurškem posegu.
Insert the needle into the skin fold with a quick, firm action.
Iglo zapičite v kožno gubo, hitro in odločno.
If blood pressure cannot be controlled, epoetin alfa treatment should be discontinued.
Če krvnega tlaka ni mogoče nadzorovati, je treba zdravljenje z epoetinom alfa prekiniti.
Take special care with other products that stimulate red blood cell production:
Bodite posebno pozorni pri drugih zdravilih, ki spodbujajo nastajanje rdečih krvnih celic:
In controlled clinical studies, use of epoetin alfa and other ESAs have been associated with decreased locoregional tumour control or decreased overall survival:
nadzorovanih kliničnih študijah je bila uporaba epoetina alfa in drugih ESA povezana z zmanjšanim lokoregionalnim nadzorom tumorjev ali zmanjšanim skupnim preživetjem:
No evidence exists that indicates that treatment with epoetin alfa alters the metabolism of other medicinal products.
Ni dokazov, ki kažejo, da zdravljenje z epoetinom alfa vpliva na metabolizem drugih zdravil.
In cell cultures of human bone marrow cells, epoetin alfa stimulates erythropoiesis specifically and does not affect leucopoiesis.
V celičnih kulturah celic človeškega kostnega mozga epoetin alfa specifično spodbuja eritropoezo in ne vpliva na levkopoezo.
This includes patients on dialysis and patients not yet on dialysis.
To vključuje tudi bolnike na dializi in bolnike, ki se še ne zdravijo z dializo.