natgillin/translations-raw huggingface dataset:
It should also not be used in the following groups: • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin; • patients with hypertension (high blood pressure) that is not controlled; • patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke; • patients who cannot receive medicines for the prevention of blood clots.
Zdravila ne smemo uporabiti tudi pri naslednjih skupinah bolnikov: • bolniki, pri katerih se je pojavila čista aplazija rdečih krvnih celic (zmanjšano ali prekinjeno nastajanje rdečih krvnih celic) po zdravljenju s katerim koli eritropoetinom, • bolniki s hipertenzijo (visokim krvnim tlakom), ki ni nadzorovana, • bolniki pred operacijo, ki imajo hude kardiovaskularne težave (s srcem in ožiljem), vključno z nedavnim miokardnim infarktom ali kapjo, • bolniki, ki ne smejo jemati zdravil za preprečevanje nastanka krvnih strdkov.
Retacrit is not recommended for subcutaneous injection in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.
Zdravilo Retacrit ni priporočljivo za podkožno injiciranje pri zdravljenju bolezni ledvic, ker so potrebne dodatne študije, s katerimi bi izključili možnost alergijskih reakcij zaradi takšnega injiciranja.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Retacrit has been shown to have a comparable quality, safety and efficacy profile to EPREX/ ERYPO.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je bilo za zdravilo Retacrit v skladu z zahtevami EU dokazano, da ima primerljivo kakovost, varnost in učinkovitost kot zdravilo EPREX/ ERYPO.
Therefore, the CHMP’ s view was that, as for EPREX/ ERYPO, the benefit outweighs the identified risks.
Zato je CHMP mnenja, da so koristi zdravila Retacrit kot tudi zdravila EPREX/ ERYPO večje od z njima povezanega znanega tveganja.
The Committee recommended that Retacrit be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Retacrit.
Which measures are being taken to ensure the safe use of Retacrit?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Retacrit?
The company that makes Retacrit will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
Podjetje, ki izdekuje zdravilo Retacrit bo zdravstvenim delavcem v vseh državah članicah zagotovilo informacijsko gradivo, ki vključuje podatke o varnosti zdravila.
The European Commission granted a marketing authorisation valid throughout the EU for Retacrit to HOSPIRA Enterprises B. V. on 18 December 2007.
Evropska Komisija je dovoljenje za promet z zdravilom Retacrit, veljavno po vsej Evropski uniji, odobrila družbi HOSPIRA Enterprises B. V. dne 18. decembra 2007.
The full EPAR for Retacrit can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Retacrit je na voljo tukaj.
1000 IU/ 0.3 ml
1000 i. e. / 0, 3 ml
2000 IU/ 0.6 ml
2000 i. e. / 0, 6 ml
0.6 ml (3333 IU/ ml)
0, 6 ml (3333 i. e. / ml)
3000 IU/ 0.9 ml
3000 i. e. / 0, 9 ml
0.9 ml (3333 IU/ ml)
0, 9 ml (3333 i. e. / ml)
Subcutaneous or intravenous use
intravenska uporaba
10000 IU / 1.0 ml
10000 i. e. / 1, 0 ml
20000 IU/ 0.5 ml
20000 i. e. / 0, 5 ml
0.5 ml (40000 IU/ ml)
0, 5 ml (40000 i. e. / ml)
30000 IU/ 0.75 ml
30000 i. e. / 0, 75 ml Raztopina za injiciranje
0.75 ml (40000 IU/ ml)
0, 75 ml (40000 i. e. / ml)
40000 IU/ 1.0 ml
40000 i. e. / 1, 0 ml
1.0 ml (40000 IU/ ml)
1, 0 ml (40000 i. e. / ml)
4 pre-filled syringes
4 napolnjenih injekcijskih brizg
0.75 ml (40000 IU/ ml)
0, 75 ml (40000
Retacrit 1000 IU/ 0.3ml solution for injection in pre-filled syringe
Retacrit 1. 000 i. e. / 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
1 pre-filled syringe with 0.3 ml solution for injection contains 1000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
1 napolnjena injekcijska brizga z 0, 3 ml raztopine za injiciranje vsebuje 1. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
The solution contains 3333 IU Epoetin zeta per ml.
Raztopina vsebuje 3. 333 i. e. epoetina zeta na ml.
*Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
* pridobljeno iz celične linije jajčnika kitajskega hrčka (CHO – ” Chinese Hamster Ovary ”) s tehnologijo rekombinantne DNA
Each pre-filled syringe contains 0.15 mg phenylalanine.
Vsaka napolnjena brizga vsebuje 0, 15 mg fenilalanina.
− Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: o Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (See section 4.4). o Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (See section 4.4). − Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). − Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme.
− Zdravljenje simptomatske anemije, povezane s kronično odpovedjo ledvic pri odraslih in pediatričnih bolnikih: o zdravljenje anemije pri odraslih in pediatričnih bolnikih s kronično odpovedjo ledvic na hemodializi ali odraslih bolnikov na peritonealni dializi (glejte poglavje 4. 4). o zdravljenje hude anemije ledvičnega izvora s spremljajočimi kliničnimi znaki, pri odraslih bolnikih z ledvično insuficienco, ki se jih še ne zdravi z dializo (glejte poglavje 4. 4). − zdravljenje anemije in zmanjšanje potrebe po transfuzijah pri odraslih bolnikih, ki prejemajo kemoterapijo zaradi čvrstih tumorje, malignega limfoma ali multiplega mieloma, in za katere je transfuzija glede na splošno stanje bolnika tvegana (npr. kardiovaskularni status, anemičnost ob začetku kemoterapije). − Zdravilo Retacrit se lahko uporablja za povečanje količine avtologne krvi pri bolnikih v programu avtologne transfuzije.
Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
5 ali več enot za moške).
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients In patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
2 Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo Pri bolnikih s kronično odpovedjo ledvic je treba zdravilo dajati intravensko (glejte poglavje 4. 4).
2 The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
Ciljna koncentracija hemoglobina je med 10 in 12 g/ dl (6, 2– 7, 5 mmol/ l), razen pri pediatričnih bolnikih, kjer mora biti koncentracija hemoglobina med 9, 5 in 11 g/ dl (5, 9– 6, 8 mmol/ l).
Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Zdravilo Retacrit je treba dajati intravensko, da bi koncentracijo hemoglobina zvečali na vrednost, ki ne presega 12 g/ dl (7, 5 mmol/ l).
Retacrit should be administered intravenously in order to increase haemoglobin to not greater than 12 g/ dL (7.5 mmol/ L) Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Zaradi razlik med posameznimi bolniki je pri bolnikih občasno mogoče opaziti individualne vrednosti hemoglobina, ki so nad ali pod želeno koncentracijo hemoglobina.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dL (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
V primeru odstopanja vrednosti hemoglobina je treba prilagoditi odmerek, pri tem pa upoštevati ciljni razpon koncentracij hemoglobina od 10 g/ dl (6, 2 mmol/ l) do 12 g/ dl (7, 5 mmol/ l).
A sustained haemoglobin level of greater than 12 g/ dl should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Navodila za primerno prilagajanje odmerka v primeru ugotovljenih vrednosti hemoglobina, ki presegajo 12 g/ dl (7, 5 mmol/ l), so navedena spodaj.
A rise in haemoglobin of greater than 2 g/ dL (1.25 mmol/ l) over a four week period should be avoided.
V času štirih tednov se morate izogibati dvigu koncentracije hemoglobina, ki presega 2 g/ dl (1, 25 mmol/ l).
Patients should be monitored closely to ensure that the lowest approved dose of Retacrit is used to provide adequate control of the symptoms of anemia.
Bolnike morate skrbno nadzorovati, da bi zagotovili uporabo najnižjega odobrenega odmerka zdravila Retacrit za primeren nadzor simptomov anemije.
In patients with chronic renal failure and clinically evident ischemic heart disease or congestive heart failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration.
Pri bolnikih s kronično ledvično odpovedjo in klinično jasno ishemično boleznijo srca ali s kongestivno srčno odpovedjo vzdrževana koncentracija hemoglobina ne sme presegati zgornje ciljne meje za koncentracijo hemoglobina.
Adult patients on haemodialysis The treatment is divided into two stages:
Odrasli bolniki na hemodializi Zdravljenje poteka v dveh stopnjah:
50 IU/ kg 3 times per week by the intravenous route.
50 i. e. / kg trikrat tedensko, intravensko.
When a dose adjustment is necessary, this should be done in steps of at least four weeks.
Pri vsakem koraku je treba odmerek zvečati ali zmanjšati za 25 i. e/ kg trikrat na teden.
Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level:
Vzdrževalna faza: prilagajanje odmerka, da se vrednost hemoglobina (Hb) ohranja na želenem nivoju:
Hb between 10 and 12 g/ dl (6.2-7.5 mmol/ l).
Hb med 10 in 12 g/ dl (6, 2- 7, 5 mmol/ l).
The recommended total weekly dose is between 75 and 300 IU/ kg by the intravenous route.
Priporočen tedenski odmerek je med 75 in 300 i. e/ kg, intravensko.
The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6 g/ dl or< 3.75 mmol/l) may require higher maintenance doses than those whose initial anaemia is less severe (Hb > 8 g/dl or> 5 mmol/l).
Klinični podatki, ki so na razpolago kažejo, da so za bolnike z zelo nizkim začetnim nivojem hemoglobina (< 6 g/ dl ali < 3, 75 mmol/ l) lahko potrebni višji vzdrževalni odmerki kot v primeru manj hude začetne anemije (Hb > 8 g/ dl ali > 5 mmol/ l).
Paediatric patients on haemodialysis The treatment is divided into two stages:
Pediatrični bolniki na hemodializi Zdravljenje poteka v dveh stopnjah:
50 IU/ kg, 3 times per week by the intravenous route.
50 i. e. / kg trikrat tedensko, intravensko.
When a dose adjustment is necessary, this should be done in steps of 25 IU/ kg, 3 times per week at intervals of at least 4 weeks until the desired goal is achieved.
Kadar je potrebno spremeniti odmerek, je treba spremembo izvesti v korakih po 25 i. e. / kg, 3 krat na teden s presledki najmanj 4 tednov, dokler se ne doseže zadana vrednost.
Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level:
Vzdrževalna faza: prilagajanje odmerka, da se vrednosti hemoglobina (Hb) ohranja na želenem nivoju:
Hb between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
Hb med 9, 5 in 11 g/ dl (5, 9- 6, 8 mmol/ l).
Dose (IU/ kg given 3x week)
Odmerek (i. e. / kg 3x na teden)
Weight (kg )< 10 10-30 > 30
Telesna masa (kg) < 10 10- 30 > 30
Median 100 75 33
mediana 100 75 33
Usual maintenance dose 75-150 60-150 30-100
običajni vzdrževalni odmerek 75- 150 60- 150 30- 100
3 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/ dl or< 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or> 4.25 mmol/l).
Klinični podatki, ki so na razpolago kažejo, da so za bolnike z zelo nizkim začetnim nivojem hemoglobina (< 6, 8 g/ dl ali < 4, 25 mmol/ l) lahko potrebni višji vzdrževalni odmerki kot v primeru manj hude začetne anemije (Hb > 6, 8 g/ dl ali > 4, 25 mmol/ l).
Adult patients on peritoneal dialysis The treatment is divided into two stages:
Odrasli bolniki na peritonealni dializi Zdravljenje poteka v dveh stopnjah:
Starting dose of 50 IU/ kg 2 times per week by the intravenous route.
začetni odmerek 50 i. e. / kg dvakrat tedensko, intravensko.
Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level:
Vzdrževalna faza: prilagajanje odmerka, za vzdrževanje nivoja hemoglobina (Hb):
Maintenance dose between 25 and 50 IU/ kg 2 times per week into 2 equal doses.
Vzdrževalni odmerek med 25 in 50 i. e. / kg dvakrat tedensko v dveh enakih odmerkih.
Starting dose of 50 IU/ kg 3 times per week by the intravenous route, followed if necessary by a dose increase with 25 IU/ kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
začetni odmerek je 50 i. e. / trikrat tedensko, intravensko, ki se ga po potrebi veča s koraki po 25 i. e. / kg (trikrat tedensko), dokler se ne doseže zadana vrednost (koraki naj si sledijo s presledkom najmanj štirih tednov):
Hb between 10 and 12 g/ dl (6.2-7.5 mmol/ l).
(Hb med 10 in 12 g/ dl (6, 2- 7, 5 mmol/ l).
Maintenance dose between 17 and 33 IU/ kg 3 times per week by the intravenous route.
Vzdrževalni odmerek med 17 in 33 i. e. / kg trikrat tedensko, intravensko.
The maximum dose should not exceed 200 IU/ kg 3 times per week.
Največji odmerek ne sme preseči 200 i. e. / kg 3 krat na teden.
− Treatment of patients with chemotherapy induced anaemia..
Zdravljenje bolnikov, pri katerih je anemijo povzročila kemoterapija
Retacrit should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10 g/ dl (6.2 mmol/ l).
Bolnikom z anemijo (npr. koncentracije hemoglobina ≤ 10 g/ dl (6, 2 mmol/ l)) je treba zdravilo Retacrit dajati subkutano.
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.
Zaradi tega mora zdravnik ocenjevati potek bolezni in stanje bolnika.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Zaradi variabilnosti koncentracij hemoglobina pri posameznikih je treba odmerek prilagoditi, pri tem pa upoštevati ciljni razpon hemoglobina od 10 g/ dl (6, 2 mmol/ l) do 12 g/ dl (7, 5 mmol/ l).
Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Izogibajte se trajni koncentraciji hemoglobina, ki presega 12 g/ dl.
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Navodila za primerno prilagajanje odmerka v primeru ugotovljenih vrednosti hemoglobina, ki presegajo 12 g/ dl (7, 5 mmol/ l), so navedena spodaj.
The initial dose is 150 IU/ kg given subcutaneously 3 times per week.
Začetni odmerek 150 i. e. / kg dajemo subkutano trikrat tedensko.
Alternatively, Retacrit can be administered at an initial dose of 450 IU/ kg subcutaneously once weekly.
Zdravilo Retacrit se lahko daje tudi enkrat tedensko subkutano z začetnim odmerkom 450 i. e. / kg.
If the haemoglobin has increased by at least 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/ kg 3 times per week or 450 IU/ kg once weekly.
Če se po 4 tednih zdravljenja hemoglobin zviša za najmanj 1 g/ dl (0, 62 mmol/ l) ali če se je število retikulocitov dvignilo ≥40. 000 celic/ µl nad osnovno vrednostjo, naj odmerek ostane pri 150 i. e. / kg trikrat tedensko ali 450 i. e. / kg enkrat tedensko.
If the haemoglobin increase is < 1 g/ dl (< 0.62 mmol/ l) and the reticulocyte count has increased < 40,000 cells/ µl above baseline, increase the dose to 300 IU/ kg 3 times per week.
Če se je hemoglobina zvišal < 1 g/ dl (0, 62 mmol/ l) ali če se je število retikulocitov dvignilo < 40. 000 celic/ µl nad osnovno vrednost, zvišamo odmerek na 300 i. e. / kg trikrat tedensko.
If after an additional 4 weeks of therapy at 300 IU/ kg 3 times per week, the haemoglobin has increased ≥ 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl the dose should remain at 300 IU/ kg 3 times per week.
Če se po dodatnih 4 tednih zdravljenja z 300 i. e. / kg trikrat tedensko hemoglobin zviša za najmanj 1 g/ dl (0, 62 mmol/ l) ali če se je število retikulocitov dvignilo ≥40. 000
However, if the haemoglobin
Ciljna koncentracija Hb
4 has increased < 1 g/ dl (< 0.62 mmol/ l) and the reticulocyte count has increased < 40,000 cells/ µl above baseline, response is unlikely and treatment should be discontinued.
Število retikulocitov zvečano za ≥ 40. 000/ μl ali zvišanje koncentracije Hb za ≥ 1 g/ dl
The recommended dosing regimen is described in the following diagram:
Število retikulocitov zvečano za < 40. 000/ μl in zvišanje nivoja Hb za < 1 g/ dl
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to maintain haemoglobin at that level.
Ko enkrat dosežete terapevtske cilje za posameznega bolnika, morate odmerek zmanjšati za 25 do 50%, da bi tako ohranili doseženo koncentracijo hemoglobina.
Dose adjustment At a rate of rise in haemoglobin of > 2 g/ dl (> 1.25 mmol/ l) per month the Retacrit dose should be reduced by about 25-50%.
Prilagajanje odmerka Če je zvišanje hemoglobina > 2 g/ dl (> 1, 25 mmol/ l) na mesec, je treba odmerek zdravila Retacrit znižati za okoli 25– 50%.
If haemoglobin level exceeds 12 g/ dl (7.5 mmol/ l), discontinue therapy until it falls to 12 g/ dl (7.5 mmol/ l) or lower and then reinstitute Retacrit therapy at a dose 25% below the previous dose.
Če je koncentracija hemoglobina nad 12 g/ dl (7, 5 mmol/ l), zdravljenje prekinemo, dokler ne pade na 12 g/ dl (7, 5 mmol/ l) ali nižje, potem pa nadaljujemo s terapijo z zdravilom Retacrit z odmerkom, ki je 25% nižji od predhodnega.
− Adult surgery patients in an autologous predonation programme.
− Odrasli kirurški bolniki v programu doniranja avtologne krvi
Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Retacrit at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
Blago anemičnim bolnikom (hematokrit 33- 39%), ki potrebujejo zalogo ≥ 4 enot krvi, je treba dajati zdravilo Retacrit v odmerku 600 i. e. / kg telesne mase dvakrat tedensko, 3 tedne pred operacijo.
5 All patients being treated with Retacrit should receive adequate iron supplementation (e. g.
Vsem bolnikom, ki dobivajo zdravilo Retacrit, je treba ves čas zdravljenja dodajati ustrezn dodatek z železom (npr.
200 mg oral elemental iron daily) throughout the course of treatment.
Z dodajanjem železa je treba začeti
Iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Retacrit therapy.
6 čim preje, celo več tednov pred začetkom avtolognega odvzema, da bi tako ob začetku terapije z zdravilom Retacrit bolnik imel visoke zaloge železa.
Intravenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.
Intravensko injiciranje Odmerek je treba injicirati najmanj 1 do 5 minut, odvisno od celotnega odmerka.
Alternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to rinse the tubing and ensure satisfactory injection of the medicinal product into the circulation.
Injiciranje se lahko opravi tudi ob koncu dialize skozi arteriovensko fistulo, ki mu sledi injiciranje natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje, da se cevke splaknejo in da se zagotovi zadovoljiv vnos zdravila v obtok.
A slower injection is preferable in patients who react to the treatment with “ flu-like” symptoms.
Pri bolnikih, ki na postopek reagirajo s simptomi podobnimi gripi, se priporoča počasneje iniciranje.
Retacrit should not be administered by intravenous infusion.
Zdravilo Retacrit se ne sme dajati z intravenozno infuzijo.
Retacrit must not be mixed with other medicinal products (see section 6.2).
Zdravilo Retacrit se ne sme mešati z drugimi zdravili (glej poglavje 6. 2).
Subcutaneous injection A maximum volume of 1 ml at one injection site should generally not be exceeded.
Subkutano injiciranje Na mestu injiciranja se v splošnem ne sme dajati volumen večji kot 1ml.
In chronic renal failure patients Retacrit has not to be administered subcutaneously.
Pri bolnikih, ki imajo kronično ledvično odpoved, Retacrita ni dovoljeno dajati subkutano.
The intravenous route has to be used (please see section 4.4 - chronic renal failure patients).
Treba je uporabiti intavensko pot (glejte poglavje 4. 4 – Bolniki s kronično ledvično odpovedjo).
− Hypersensitivity to the active substance or to any of the excipients. − Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin must not receive Retacrit or any other erythropoietin (see section 4.4). − Uncontrolled hypertension. − In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease. − Patients who for any reason cannot receive adequate antithrombotic prophylaxis.
− Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov. − Bolniki, pri katerih po zdravljenju s katerimkoli eritropoetinom pride do čiste aplazije rdečih krvnih celic (PRCA - "Pure Red Cell Aplasia"), zdravila Retacrit ali kateregakoli drugega eritropoetina ne smejo dobivati (glejte poglavje 4. 4). − Nekontrolirana hipertenzija. − Pri indikaciji "povečanje količine avtologne krvi": miokardni infarkt ali kap v preteklem mesecu, nestabilna angina pektoris, povečano tveganje globoke venske tromboze kot je venska tromboembolična bolezen v anamnezi. − Bolniki, ki iz kakršnegakoli razloga ne morejo prejemati ustrezne profilakse proti trombozi.
6 All other causes of anaemia (iron deficiency, haemolysis, blood loss, vitamin B12- or folate deficiencies) should be considered and treated prior to initiating and during therapy with Retacrit.
Vse druge vzroke anemije (pomanjkanje železa, hemoliza, izguba krvi, pomanjkanje folne kisline ali vitamina B12) je treba izključiti oziroma zdraviti pred začetkom zdravljenja in med zdravljenjem z zdravilom Retacrit.
In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume.
V večini primerov se vrednosti feritina v serumu znižajo hkrati z zvišanjem
In order to ensure optimum response to erythropoietin, adequate iron stores should be assured: − iron supplementation, e. g.
Da je odziv na eritropoetin optimalen, je treba poskrbeti za ustrezne zaloge železa: − dodajanje železa, npr.