natgillin/translations-raw huggingface dataset:
It is available in vials and in pre-filled syringes at various strengths ranging between 50 and 1,000 micrograms per millilitre.
Na voljo je v vialah in napolnjenih injekcijskih brizgah različnih jakosti v razponu od 50 do 1000 mikrogramov na mililiter.
What is MIRCERA used for?
Za kaj se zdravilo MIRCERA uporablja?
MIRCERA is used to treat anaemia (low red blood cell counts) in patients who have chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly).
Zdravilo MIRCERA se uporablja za zdravljenje anemije (nizkega števila rdečih krvničk) pri bolnikih s kronično ledvično boleznijo (dolgotrajnim, progresivnim zmanjšanjem sposobnosti ledvic, da bi pravilno delovale).
How is MIRCERA used?
Kako se zdravilo MIRCERA uporablja?
Treatment with MIRCERA must be initiated under the supervision of a doctor who has experience in the management of patients with kidney disease.
Zdravljenje z zdravilom MIRCERA je treba uvesti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z ledvično boleznijo.
The starting dose and the frequency of dosing depend on whether MIRCERA is replacing another medicine used to stimulate the production of red blood cells or not.
Začetni odmerek in pogostost odmerjanja sta odvisna od tega, ali zdravilo MIRCERA nadomešča drugo zdravilo, ki se uporablja za stimulacijo tvorbe rdečih krvničk, ali ne.
Patients who have not been receiving one of these medicines need to start with a dose of 0.6 micrograms per kilogram body weight twice a month.
Bolniki, ki niso prejemali nobenega izmed teh zdravil, morajo začeti z odmerkom 0, 6 mikrogramov na kilogram telesne mase dvakrat mesečno.
Patients who have been receiving one of these medicines need to receive MIRCERA once a month, with the dose ranging between 120 and 360 micrograms.
Bolniki, ki so prejemali katero izmed teh zdravil, morajo prejemati zdravilo MIRCERA enkrat mesečno v odmerku med 120 in 360 mikrogramov.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Več podrobnosti najdete v Povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
In all cases, doses should be adjusted depending on the levels of haemoglobin (a protein in red blood cells that carries oxygen around the body), which should be monitored every two weeks until they are stable, and then periodically.
V vseh primerih je treba odmerke prilagoditi glede na koncentracijo hemoglobina (beljakovine v rdečih krvničkah, ki prenaša kisik po telesu), ki jo je treba preverjati vsaka dva tedna, dokler se ne stabilizira, kasneje pa periodično.
MIRCERA is intended for long-term use.
Zdravilo MIRCERA je predvideno za dolgotrajno uporabo.
MIRCERA is given as an injection, either subcutaneously (under the skin) or intravenously (into a vein).
Zdravilo MIRCERA se daje kot injekcija bodisi subkutano (pod kožo) bodisi intravensko (v veno).
Patients can inject themselves subcutaneously or intravenously through a haemodialysis line (a tube leading into a vein) once they have been trained.
Po ustrezni priučitvi si lahko bolniki sami dajo injekcijo subkutano ali intravensko prek hemodializne krvne linije (cevke, ki vodi v veno).
MIRCERA should be used with caution in patients who have severe problems with their liver.
Zdravilo MIRCERA je treba pri bolnikih, ki imajo resne težave z jetri, uporabljati previdno.
It is not recommended for use in children, due to a lack of information on the safety and effectiveness of the medicine in this group.
Uporaba zdravila pri otrocih zaradi pomanjkanja informacij o varnosti in učinkovitosti zdravila v tej skupini ni priporočljiva.
How does MIRCERA work?
Kako zdravilo MIRCERA deluje?
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Hormon, imenovan eritropoetin, stimulira tvorbo rdečih krvničk iz kostnega mozga.
The active substance in MIRCERA, methoxy polyethylene glycol- epoetin beta, can stimulate red blood cells production like erythropoietin does.
Eritropoetin tvorijo ledvice, zato imajo bolniki s kronično ledvično boleznijo pomanjkanje eritropoetina, kar povzroča anemijo.
The way it interacts with the receptor is slightly 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Zdravilna učinkovina zdravila MIRCERA, metoksipolietilenglikol epoetin beta, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged different from natural erythropoietin, and this gives it a longer effect.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged lahko stimulira tvorjenje rdečih krvničk enako kot eritropoetin.
It is also cleared from the body less quickly.
To je mogoče zato, ker se lahko veže na iste receptorje kot eritropoetin.
As a result, it can be given less often than other medicines derived from erythropoietin.
Posledično ga je mogoče dajati manj pogosto kot druga zdravila, izhajajoča iz eritropoetina.
The active substance in MIRCERA is made up of epoetin beta bound to a chemical called methoxy- polyethylene glycol.
Zdravilna učinkovina zdravila MIRCERA je sestavljena iz epoetina beta, vezanega na kemijsko snov, imenovano metoksipolietilenglikol.
The epoetin beta is produced by ‘ recombinant DNA technology’: it is made by a cell that has received a gene, which makes it able to produce epoetin beta.
Epoetin beta se proizvaja s „ tehnologijo rekombinantne DNK “: proizvaja ga celica, ki je prejela gen, ki ji omogoča tvorjenje epoetina beta.
How has MIRCERA been studied?
Kako je bilo zdravilo MIRCERA raziskano?
The effects of MIRCERA were first tested in experimental models before being studied in humans.
Učinki zdravila MIRCERA so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
MIRCERA has been studied in six main studies involving a total of 2,399 adults with anaemia associated with chronic kidney disease, where it was compared with other medicines used to stimulate red blood cell production.
Zdravilo MIRCERA so preučevali v šestih glavnih študijah, ki so vključevale skupaj 2399 odraslih z anemijo, povezano s kronično ledvično boleznijo, v katerih so ga primerjali z drugimi zdravili, ki se uporabljajo za stimulacijo tvorjenja rdečih krvničk.
Two of these studies involved patients who were starting treatment for anaemia.
Dve izmed teh raziskav sta vključevali bolnike, ki so se začeli zdraviti za anemijo.
The first, in 181 patients on dialysis (a blood clearance technique used in advanced chronic kidney disease), looked at MIRCERA injected intravenously every two weeks over 24 weeks and compared it with epoetin alfa or beta.
V prvi študiji s 181 bolniki na dializi (tehniki čiščenja krvi, ki se uporablja pri napredovali kronični ledvični bolezni) so preučevali zdravilo MIRCERA, injicirano intravensko vsaka dva tedna 24 tednov, in ga primerjali z epoetinom alfa ali beta.
The second study, in 324 patients not on dialysis, looked at MIRCERA injected subcutaneously every two weeks over 28 weeks, comparing it with darbepoetin alfa.
V drugi študiji s 324 bolniki, ki niso bili na dializi, so preučevali zdravilo MIRCERA, injicirano subkutano vsaka dva tedna 28 tednov, in ga primerjali z darbepoetinom alfa.
The other four studies (in 1,894 patients) were carried out in patients on dialysis who had already been receiving medicines to stimulate red blood cell production.
Druge štiri študije (s 1894 bolniki) so izvajali z bolniki na dializi, ki so že predhodno prejemali zdravila za stimulacijo tvorjenja rdečih krvničk.
In these studies, patients either remained on the medicines they were already receiving, or changed to MIRCERA, given intravenously or subcutaneously every two or four weeks, and the effectiveness of the two treatment options was compared.
V teh študijah so bolniki še naprej jemali zdravila, ki so jih že prejemali, ali pa namesto njih jemali zdravilo MIRCERA, dajano intravensko ali subkutano vsaka dva ali štiri tedne; v okviru teh raziskav so primerjali učinkovitost obeh možnosti zdravljenja.
The studies lasted 36 weeks.
Študije so trajale 36 tednov.
Most patients also received iron to prevent deficiency (low iron levels) during the studies.
Večina bolnikov je med študijami prejemala tudi železo za preprečevanje pomanjkanja (nizke ravni železa).
What benefit has MIRCERA shown during the studies?
Kakšne koristi je zdravilo MIRCERA izkazalo med raziskavami?
MIRCERA was as effective as the comparator medicines in correcting and maintaining haemoglobin levels.
Zdravilo MIRCERA je bilo pri uravnavanju in vzdrževanju koncentracije hemoglobina enako učinkovito kot primerjalna zdravila.
In the studies of patients starting treatment for anaemia for the first time, 126 (93%) of the 135 patients receiving MIRCERA in the first study, and 158 (98%) of the 162 receiving it in the second had a clinically significant increase in haemoglobin levels between the start and end of the studies.
V študijah z bolniki, ki so se prvič začeli zdraviti za anemijo, je bilo v prvi študiji pri 126 (93%) izmed 135 bolnikov, ki so prejemali zdravilo MIRCERA, in v drugi študiji 158 (98%) izmed 162 bolnikov, ki so prejemali to zdravilo, ugotovljeno klinično značilno povečanje koncentracije hemoglobina v obdobju med začetkom in koncem raziskav.
The second study showed that patients taking MIRCERA and those taking darbepoetin alfa had similar increases in haemoglobin levels (around 2 g/ dl).
Druga študija je pokazala, da je bilo pri bolnikih, ki so jemali zdravilo MIRCERA, in bolnikih, ki so jemali darbepoetin alfa, opaženo podobno povečanje ravni hemoglobina (približno 2 g/ dl).
In the studies of patients who had already been receiving medicines to stimulate red blood cell production, patients who changed to MIRCERA maintained their haemoglobin levels as effectively as the patients who remained on their existing medicines.
V študijah bolnikov, ki so že prejemali zdravila za stimulacijo tvorjenja rdečih krvničk, so se pri bolnikih, ki so prešli na zdravilo MIRCERA, koncentracije hemoglobina vzdrževale enako učinkovito kot pri bolnikih, ki so nadaljevali z jemanjem obstoječih zdravil.
What is the risk associated with MIRCERA?
Kakšna tveganja so povezana z zdravilom MIRCERA?
The most common side effect with MIRCERA (seen in between 1 and 10 patients in 100) is hypertension (high blood pressure).
Najpogostejši neželeni učinek zdravila MIRCERA (opažen pri 1 do 10 bolnikih izmed 100) je hipertenzija (visok krvni tlak).
For the full list of all side effects reported with MIRCERA, see the Package Leaflet.
Celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila MIRCERA, najdete v Navodilu za uporabo.
MIRCERA should not be used in people who may be hypersensitive (allergic) to methoxy polyethylene glycol-epoetin beta or any of the other ingredients.
Zdravila MIRCERA ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) metoksipolietilenglikol epoetin beta ali katerokoli drugo sestavino.
It should also not be used in patients who have hypertension that is not controlled.
Prav tako ga ne smejo uporabljati bolniki s hipertenzijo, ki ni nadzorovana.
Why has MIRCERA been approved?
Zakaj je bilo zdravilo MIRCERA odobreno?
The Committee for Medicinal Products for Human Use (CHMP) concluded that MIRCERA corrected and maintained haemoglobin levels in patients with chronic kidney disease and that its effects are comparable with those of other epoetins.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da zdravilo MIRCERA uravnava in vzdržuje koncentracijo hemoglobina pri bolnikih s kronično ledvično boleznijo in da so njegovi učinki primerljivi z učinki drugih epoetinov.
It decided that MIRCERA’ s benefits are greater than its risks for the treatment of anaemia associated with chronic kidney disease.
Odločil je, da so koristi zdravila MIRCERA pri zdravljenju anemije, povezane s kronično ledvično boleznijo, večje od z njim povezanih tveganj.
The Committee recommended that MIRCERA be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo MIRCERA odobri dovoljenje za promet.
against erythropoietin (these antibodies may develop during treatment and can reduce its effectiveness).
Podjetje bo na podlagi zahteve zdravnika zagotovilo tudi brezplačno testiranje na protitelesa proti eritropoetinu (ta protitelesa se lahko razvijejo med zdravljenjem in lahko zmanjšajo njegovo učinkovitost).
Other information about MIRCERA:
Druge informacije o zdravilu MIRCERA:
The European Commission granted a marketing authorisation valid throughout the European Union for MIRCERA to Roche Registration Limited on 20 July 2007.
Evropska komisija je dovoljenje za promet z zdravilom MIRCERA, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 20. julija 2007.
The full EPAR for MIRCERA can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo MIRCERA je na voljo tukaj.
100 µg/ 1ml
100 µg/ 1 ml
200 µg/ 1ml
200 µg/ 1 ml
300 µg/ 1ml
300 µg/ 1 ml
400 µg/ 1ml
400 µg/ 1 ml
600 µg/ 1ml
600 µg/ 1 ml
1000 µg/ 1ml
1000 µg/ 1 ml
MIRCERA 50 micrograms/ ml solution for injection
MIRCERA 50 mikrogramov/ ml raztopina za injiciranje
1 ml (one vial) contains 50 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (ena viala) vsebuje 50 mikrogramov metoksipolietilenglikol epoetina beta *.
*Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG).
* Beljakovina, pridobljena iz celične kulture jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA, kovalentno vezana na linearni metoksipolietilenglikol (PEG).
The potency of methoxy polyethylene glycol-epoetin beta should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
Jakosti metoksipolietilenglikol epoetina beta ne smete primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin iz istega terapevtskega razreda.
For more information, see section 5.1.
Za dodatne informacije glejte poglavje 5. 1.
Treatment of symptomatic anaemia associated with chronic kidney disease (CKD).
Zdravljenje simptomatske anemije, povezane s kronično ledvično boleznijo.
The safety and efficacy of MIRCERA therapy in other indications has not been established.
Varnost in učinkovitost zdravljenja z zdravilom MIRCERA pri drugih indikacijah nista bili ugotovljeni.
Treatment of symptomatic anaemia in adult chronic kidney disease patients Treatment with MIRCERA has to be initiated under the supervision of a physician experienced in the management of patients with renal impairment.
Zdravljenje simptomatske anemije pri odraslih bolnikih s kronično ledvično boleznijo Zdravljenje z zdravilom MIRCERA je treba uvesti pod nadzorom zdravnika z izkušnjami pri zdravljenju bolnikov z ledvično okvaro.
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.
MIRCERA should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/ dl (7.45 mmol/ l).
Zdravilo MIRCERA dajemo subkutano ali intravensko, da bi povečali koncentracijo hemoglobina do največ 12 g/ dl (7, 45 mmol/ l).
MIRCERA can be injected subcutaneously in the abdomen, arm or thigh.
Zdravilo MIRCERA lahko injiciramo subkutano v trebuh, roko ali stegno.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl (6.21 mmol/ l) to 12 g/ dl (7.45 mmol/ l).
Razlike v koncentraciji hemoglobina urejamo z uravnavanjem odmerkov, pri čemer upoštevamo, da je ciljno območje koncentracije hemoglobina od 10 g/ dl (6, 21 mmol/ l) do 12 g/ dl (7, 45 mmol/ l).
A sustained haemoglobin level of greater than 12 g/ dl (7.45 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.45 mmol/ l) are observed are described below.
Smernice za ustrezno prilagajanje odmerkov, ko koncentracija hemoglobina preseže 12 g/ dl (7, 45 mmol/ l), so opisane spodaj.
A rise in haemoglobin of greater than 2 g/ dl (1.24 mmol/ l) over a four-week period should be avoided.
Povečanju koncentracije hemoglobina za več kot 2 g/ dl (1, 24 mmol/ l) v štirih tednih se je treba izogibati.
2 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
2 Bolnike je treba pozorno spremljati, da lahko simptome anemije ustrezno nadzorujemo s čim manjšim odobrenim odmerkom zdravila MIRCERA.
The recommended starting dose is 0.6 microgram/ kg body weight, administered once every two weeks as a single intravenous or subcutaneous injection in order to increase haemoglobin levels to greater than 10 g/ dl (6.21 mmol/ l).
Bolniki, ki se trenutno ne zdravijo z zdravili za stimulacijo eritropoeze Priporočeni začetni odmerek 0, 6 mikrograma/ kg telesne mase damo enkrat na dva tedna kot eno intravensko ali subkutano injekcijo z namenom, da bi povečali koncentracijo hemoglobina nad 10 g/ dl (6, 21 mmol/ l).
The dose may be increased by approximately 25% of the previous dose if the rate of rise in haemoglobin is less than 1.0 g/ dl (0.621 mmol/ l) over a month.
Če se je koncentracija hemoglobina v enem mesecu povečala za manj kot 1, 0 g/ dl (0, 621 mmol/ l), lahko odmerek zdravila povečate za približno 25%.
Further increases of approximately 25% may be made at monthly intervals until the individual target haemoglobin level is obtained.
Dokler bolniki ne dosežejo svojih ciljnih koncentracij hemoglobina, lahko odmerek povečujete po približno 25% v mesečnih presledkih.
If the rate of rise in haemoglobin is greater than 2 g/ dl (1.24 mmol/ l) in one month or if the haemoglobin level is increasing and approaching 12 g/ dl (7.45 mmol/ l), the dose is to be reduced by approximately 25%.
Če se je koncentracija hemoglobina v enem mesecu povečala za več kot 2 g/ dl (1, 24 mmol/ l) ali če se koncentracija hemoglobina povečuje in približuje 12 g/ dl (7, 45 mmol/ l), odmerek zdravila zmanjšajte za približno 25%.
If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Zdravljenje začnite znova z odmerkom, ki je približno 25% manjši od prejšnjega.
After dose interruption a haemoglobin decrease of approximately 0.35 g/ dl (0.22 mmol/ l) per week is expected.
Po prekinitvi dajanja je pričakovani padec koncentracije hemoglobina približno 0, 35 g/ dl (0, 22 mmol/ l) na teden.
If the haemoglobin concentration above 10 g/ dl (6.21 mmol/ l) is reached for the individual patient, MIRCERA may be administered once-monthly using the dose equal to twice the previous once-every– two-weeks dose.
Odmerek je enak dvakratnemu, ki ga je bolnik prejel enkrat na dva tedna.
Patients currently treated with an ESA:
Bolniki, ki se trenutno zdravijo z zdravili za stimulacijo eritropoeze Bolniki, ki se trenutno zdravijo z zdravili za stimulacijo eritropoeze, lahko preidejo na zdravilo MIRCERA z odmerjanjem enkrat na mesec v eni intravenski ali subkutani injekciji.
Patients currently treated with an ESA can be switched to MIRCERA administered once a month as a single intravenous or subcutaneous injection.
Začetni odmerek metoksipolietilenglikol epoetina beta je izračunan na osnovi prejšnjega tedenskega odmerka darbepoetina alfa ali epoetina ob času zamenjave, kot je opisano v preglednici 1.
The starting dose of methoxy polyethylene glycol- epoetin beta is based on the calculated previous weekly dose of darbepoetin alfa or epoetin at the time of substitution as described in Table 1.
Preglednica 1.
The first injection should start at the next scheduled dose of the previously administered darbepoetin alfa or epoetin.
Prejšnji tedenski Prejšnji tedenski
Table 1:
Mesečni odmerek
MIRCERA starting doses
odmerek darbepoetina odmerek
Previous weekly Previous weekly
dan intravensko ali
Monthly MIRCERA
intravensko ali
darb
subkutano
epoetin alfa epoetin
(mikrogram/ teden)
intravenous or
subkutano (i. e. / teden)
intravenous or intravenous or
(mikrogram/ enkrat na mesec)
subcutaneous dose
< 8. 000
subcutaneous dose (microgram/ week )< 40 40-80 > 80
40
subcutaneous dose (IU/ week )< 8000 8000-16000 > 16000
8. 000 do 16. 000 > 16. 000
If a dose adjustment is required to maintain the target haemoglobin concentration above 10 g/ dl (6.21 mmol/ l), the monthly dose may be increased by approximately 25%.
Če je za vzdrževanje koncentracije hemoglobina nad 10 g/ dl (6, 21 mmol/ l) potrebna prilagoditev odmerka, lahko mesečni odmerek povečate za približno 25%.
If the rate of rise in haemoglobin is greater than 2 g/ dl (1.24 mmol/ l) over a month or if the haemoglobin level is increasing and approaching 12 g/ dl (7.45 mmol/ l), the dose is to be reduced by approximately 25%.
Če se je koncentracija hemoglobina v enem mesecu povečala za več kot 2 g/ dl (1, 24 mmol/ l) ali če se koncentracija hemoglobina povečuje in približuje 12 g/ dl (7, 45 mmol/ l), odmerek zmanjšajte za približno 25%.
3 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
3 Ker so izkušnje z zdravljenjem pri bolnikih na peritonealni dializi omejene, je pri teh bolnikih priporočljivo redno spremljanje koncentracij hemoglobina in dosledno upoštevanje navodil za prilagajanje odmerkov.
Treatment interruption Treatment with MIRCERA is normally long-term.
Prekinitev zdravljenja Zdravljenje z zdravilom MIRCERA je običajno dolgotrajno.
Missed dose If one dose of MIRCERA is missed, the missed dose is to be administered as soon as possible and administration of MIRCERA is to be restarted at the prescribed dosing frequency.
Izpuščeni odmerek Če je izpuščen en odmerek zdravila MIRCERA, ga je treba dati takoj, ko je mogoče, nato pa odmerjanje nadaljevati po predpisani shemi.
Paediatric use MIRCERA is not recommended for use in children and adolescents below 18 years due to a lack of safety and efficacy data.
Uporaba pri otrocih Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila MIRCERA pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
Elderly patients In clinical studies 24% of patients treated with MIRCERA were aged 65 to 74 years, while 20% were aged 75 years and over.
Starejši bolniki V kliničnih preskušanjih je bilo 24% bolnikov, zdravljenih z zdravilom MIRCERA, starih od 65 do 74 let, 20% pa 75 let in več.
Patients with hepatic impairment No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairment (see section 5.2).
Bolniki z jetrno okvaro Pri bolnikih z jetrno okvaro začetnega odmerka ali smernic za prilagajanje odmerkov ni potrebno spreminjati (glejte poglavje 5. 2).
Uncontrolled hypertension
Nenadzorovana hipertenzija.
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 microgram/ l or with transferrin saturation below 20%.
Jemanje železovih pripravkov je priporočljivo za vse bolnike, ki imajo serumsko koncentracijo feritina pod 100 mikrogramov/ l ali nasičenost transferina pod 20%.
Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with ESAs.
Ugotovljeno je, da ta protitelesa navzkrižno reagirajo z vsemi zdravili, ki spodbujajo eritropoezo.