natgillin/translations-raw huggingface dataset:
NeoRecormon should be used with caution in the presence of refractory anaemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure.
Zdravilo NeoRecormon moramo uporabljati previdno pri refraktarni anemiji s čezmernim številom blastnih celic v stanju preobrazbe, epilepsiji, trombocitozi in pri kronični jetrni odpovedi.
Caution should be exercised with escalation of NeoRecormon doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Pri povečevanju odmerkov zdravila NeoRecormon pri bolnikih s kronično ledvično odpovedjo je potrebna previdnost, ker so veliki kumulativni odmerki epoetina lahko povezani s povečanjem tveganja umrljivosti, resnih srčnožilnih in možganskožilnih dogodkov.
10 Prepare the syringe and needle: follow steps 11 to 14.
10 Pripravite injekcijsko brizgo in iglo: sledite korakom od 11 do 14.
· Keep the syringe and needle and the puncture-resistant or sharps disposal container out of reach of children.
• Injekcijsko brizgo, iglo in vsebnik za odpadne ostre predmete shranjujte nedosegljivo otrokom.
If you think you have injected more NeoRecormon than you should, contact your doctor.
Če mislite, da ste si injicirali več zdravila NeoRecormon, kot bi smeli, obvestite zdravnika.
Do not use the syringe if the liquid is cloudy, discoloured, or has particles.
Injekcijske brizge ne uporabljajte, če je tekočina motna, obarvana ali vsebuje delce.
The following instructions explain how to give an injection of NeoRecormon.
Naslednja navodila pojasnjujejo, kako dati injekcijo zdravila NeoRecormon.
Patients should be monitored closely to ensure that the lowest approved effective dose of NeoRecormon is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below to 12g/dl (7.45mmol/l).
Bolnike je treba pozorno spremljati, da lahko z najmanjšim odobrenim učinkovitim odmerkom zdravila NeoRecormon simptome anemije ustrezno nadzorujemo in hkrati vzdržujemo koncentracijo hemoglobina pod 12 g/dl (7,45 mmol/l) ali na tej vrednosti.
blood volume [ml] = 41 [ml/kg] x body weight [kg] + 1200 [ml]
volumen krvi (ml) = 41 (ml/kg) x telesna masa (kg) + 1200 (ml)
(5) Remove the needle cover and carefully expel air from the needle by holding the syringe vertically and gently pressing the plunger upwards until a bead of liquid appears at the needle tip.
(5) Odstranite igelno zaščito in pazljivo odstranite zrak iz igle tako, da brizgo držite navpično, bat pa počasi potiskate navzgor, dokler se na konici igle ne pojavi kapljica tekočine.
9 Choose an injection site: · The recommended injection sites are the top of your thigh or the lower part of your abdomen below the belly button.
• Priporočena mesta injiciranja so vrh stegna ali spodnji del trebuha pod popkom.
If you develop a serious rash or another of these skin symptoms, stop taking NeoRecormon and contact your doctor or seek medical attention immediately.
Če se je pri vas pojavil hud izpuščaj ali eden od teh kožnih simptomov, prenehajte z jemanjem zdravila NeoRecormon in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 80 IU/kg per injection, given three times per week.
Po 4 tednih bo vaš zdravnik opravil preiskave in v primeru, da odziv na zdravljenje ne bo zadosten, vaš odmerek morda zvišal na 80 i.e./kg telesne mase, dano trikrat na teden.
Lyophilisate: Vial (type I glass) with a stopper (teflonised rubber).
Liofilizat: viala (steklo tipa I) z zamaškom (guma s teflonsko prevleko).
· If you have low blood pressure or shunt complications you may be at risk of shunt thrombosis (a blood clot in the vessel used for connection to the dialysis system).
• Če imate nizek krvni tlak ali zaplete s spojem, imate lahko povečano tveganje za obvodno trombozo (krvni strdek v cevki za povezavo z dializnim sistemom).
In a randomised, double-blind, placebo-controlled study of 4,038 chronic renal failure patients not on dialysis with type 2 diabetes and haemoglobin levels ≤ 11 g/dL, patients received either treatment with darbepoetin alfa to target haemoglobin levels of 13 g/dL or placebo (see section 4.4).
V randomizirani, dvojno slepi, s placebom kontrolirani študiji s 4038 bolniki s kronično ledvično boleznijo, ki niso bili na dializi in sladkorno boleznijo tipa 2, ter koncentracijo hemoglobina ≤ 11 g/dl, so bolniki prejeli zdravljenje z darbepoetinom alfa, da bi dosegli koncentracijo hemoglobina 13 g/dl, ali placebo (glejte poglavje 4.4).
If you are a kidney patient under haemodialysis, your doctor may adjust your dose of heparin.
Če ste ledvični bolnik na dializi, vam bo morda zdravnik moral prilagoditi odmerek heparina.
Male patients
Bolniki
Required amount of pre-donated blood Required amount of pre-donated blood [units]
Potrebna količina vnaprej darovane krvi
· Do not touch the tip of the syringe.
• Ne dotikajte se konice brizge.
· Hold the syringe by the barrel and push the needle onto the syringe (B).
• Injekcijsko brizgo primite za telo in nanjo pritrdite injekcijsko iglo (B).
· Do not use if the expiration date has passed, if the syringe is dropped or damaged, or if the carton appears to be tampered with.
• Ne uporabljajte zdravila, če je rok uporabnosti potekel, če vam je injekcijska brizga padla ali je poškodovana ali če se vam zdi, da je bila škatla odprta.
Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of NeoRecormon.
Večja preobremenitev z aluminijem, ki je posledica zdravljenja ledvične odpovedi, lahko zmanjša učinkovitost zdravila NeoRecormon.
blood volume [ml] = 44 [ml/kg] x body weight [kg] + 1600 [ml] (body weight ³ 45 kg)
volumen krvi (ml) = 44 (ml/kg) x telesna masa (kg) + 1600 (ml) (telesna masa ≥ 45 kg)
He or she may raise or lower your dose, or interrupt your treatment according to the test results.
Vaš odmerek vam lahko glede na rezultat krvnih preiskav zviša ali zniža ali zdravljenje prekine.
In patients with a poor haemoglobin response to NeoRecormon, alternative explanations for the poor response should be considered (see sections 4.4 and 5.1).
Pri bolnikih s slabim odzivom hemoglobina na zdravilo NeoRecormon je treba razmisliti o drugih razlagah za slab odziv (glejte poglavji 4.4 in 5.1).
The most frequent adverse reaction during treatment with NeoRecormon is an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase (see section 4.4).
Najpogostejši neželeni učinek med zdravljenjem z zdravilom NeoRecormon je zvišanje krvnega tlaka ali poslabšanje obstoječe hipertenzije, ki se pojavljata zlasti pri hitrem povečanju vrednosti hematokrita (glejte poglavje 4.4).
NeoRecormon is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Zdravilo NeoRecormon spada v skupino zdravil, ki spodbujajo nastajanje rdečih krvnih celic na enak način kot humana beljakovina eritropoetin.
Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.
Izsledki kliničnih raziskav pri otrocih so pokazali, da povprečno potrebujejo večji odmerek zdravila NeoRecormon, čim mlajši so.
Clean the skin above the vein with an alcohol swab and let dry.
Očistite kožo nad veno z alkoholnim zložencem in pustite, da se posuši.
These include fever, chills, headaches, pain in the limbs, bone pain and/or feeling generally unwell.
Ti vključujejo zvišano telesno temperaturo, mrzlico, glavobole, bolečino v udih, bolečino v kosteh in/ali splošno slabo počutje.
NeoRecormon is provided in the following pack-sizes:
Zdravilo NeoRecormon je na voljo v naslednjih velikostih pakiranj:
Other medicines and NeoRecormon
Druga zdravila in zdravilo NeoRecormon
If the solution is given into your vein it should be injected over about 2 minutes, eg people on haemodialysis will receive the injection via the arterio-venous fistula at the end of dialysis.
Če se raztopina daje v veno, jo je treba injicirati v času 2 minut, bolniki na dializi bodo prejeli injekcijo prek arteriovenske fistule po koncu dialize.
EXP The reconstituted solution is stable for 1 month if stored at 2°C - 8°C (in a refrigerator)
Pripravljena raztopina je stabilna do 1 meseca, če jo shranjujemo pri temperaturi med 2 °C in 8 °C (v hladilniku)
If blood pressure rises cannot be controlled by drug therapy, a transient interruption of NeoRecormon therapy is recommended.
Kadar zvišanega krvnega tlaka z zdravili ne moremo uspešno obvladovati, je zdravljenje z zdravilom NeoRecormon priporočljivo začasno prekiniti.
If you are a kidney patient under haemodialysis and at risk of shunt thrombosis, blood clots (thromboses) may form in your shunt (vessel used for connection to the dialysis system).
Če ste ledvični bolnik na dializi in imate tveganje za obvodno trombozo, se lahko v vašem spoju (cevčica za povezavo z dializnim sistemom) tvorijo krvni strdki (tromboze).
· Anaemia in premature infants
• Anemija pri nedonošenčkih
Administering the intravenous injection Preparing for injection: follow steps 1 to 8
Uporaba intravenske injekcije Priprava na injiciranje: sledite korakom od 1 do 8.
Pregnancy, breast-feeding and fertilty
Nosečnost, dojenje in plodnost
The weekly dose can also be divided into daily doses.
Tedenski odmerek lahko razdelimo na dnevne odmerke.
Treatment with NeoRecormon is divided into two stages:
Zdravljenje z zdravilom NeoRecormon poteka v dveh stopnjah:
NeoRecormon therapy is started by a doctor who is an expert on your condition.
Zdravljenje z zdravilom NeoRecormon bo začel zdravnik, ki ima izkušnje z vašo boleznijo.
· If you have any further questions, ask your doctor or pharmacist.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
If you have missed an injection, or injected too little, talk to your doctor.
Če ste izpustili injekcijo ali ste si injicirali premajhen odmerek, se posvetujte z zdravnikom.
L-Glutamic acid, L-Phenylalanine.
L-glutaminska kislina, L-fenilalanin.
To maintain an Hb of between 10 and 12 g/dl, the dosage is initially reduced to half of the previously administered amount.
Da bi ohranili koncentracijo hemoglobina med 10 in 12 g/dl, odmerek najprej zmanjšamo na polovico dotedanjega.
15 Pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action.
15 Na izbranem mestu injiciranja naredite kožno gubo in s hitrim čvrstim gibom v celoti vstavite iglo pod kotom 45° do 90°.
If any of these apply to you, or might apply, tell your doctor at once.
Če se kar koli izmed naštetega nanaša ali bi se lahko nanašalo na vas, se takoj posvetujte z zdravnikom.
If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses of NeoRecormon.
Če se ne boste ustrezno odzvali na zdravilo NeoRecormon, bo zdravnik preveril vaš odmerek in vam povedal, če boste morali spremeniti odmerke zdravila NeoRecormon.
One ampoule contains 10 ml solvent (water for injections with benzyl alcohol and benzalkonium chloride as preservatives).
Ena ampula vsebuje 10 ml vehikla (voda za injekcije z benzilalkoholom in benzalkonijevim kloridom kot konzervansoma).
· Do not use if the syringe has been dropped or damaged.
• Injekcijske brizge ne uporabljajte, če vam je padla ali se je poškodovala.
In patients with baseline haemoglobin ≤ 10 g/dl (n=899), the hazard ratio point estimate for survival was 0.98 (95 % CI 0.68 to 1.40).
Pri bolnikih s koncentracijo hemoglobina < 10 g/dl ob začetku zdravljenja (n = 899), je bila ocena razmerja ogroženosti za preživetje 0,98 (95-% interval zaupanja 0,68 do 1,40).
- Treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy.
- Zdravljenje simptomatske anemije pri odraslih bolnikih z malignomi nemieloične vrste, ki prejemajo kemoterapijo.
If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses.
Če se na zdravilo NeoRecormon ne boste ustrezno odzvali, bo zdravnik preveril odmerek zdravila in vas obvestil, če boste odmerke morali spremeniti.
Remove one needle from the pack, fix it on the syringe and remove the protective cap from the needle.
Iz ovojnine vzemite eno priloženo iglo, jo namestite na brizgo in odstranite zaščitni pokrovček z igle.
One vial contains 50,000 IU (international units) epoetin beta.
Ena viala vsebuje 50.000 i.e. (mednarodnih enot) epoetina beta.
Store at +2°C to +8°C
2 °C in 8 °C.
Even at very high serum levels no symptoms of poisoning have been observed.
Celo pri zelo visokih serumskih koncentracijah ne poročajo o simptomih zastrupitve.
Prevention of anaemia of prematurity
Preprečevanje anemije pri nedonošenčkih
The following Instructions for Use explains how to give an intravenous injection of NeoRecormon.
Naslednja navodila pojasnjujejo, kako dati intravensko injekcijo zdravila NeoRecormon.
10 Prepare the syringe and needle: follow steps 11 to 14 15 Insert the needle into the vein.
10 Pripravite injekcijsko brizgo in iglo: sledite korakom od 11 do 14. 15 Iglo vstavite v dostop za injiciranje (sledite navodilom proizvajalca dostopa za injiciranje)
The ability to donate blood depends predominantly on the patient's blood volume and baseline PCV.
Sposobnost za darovanje krvi je predvsem odvisna od bolnikovega volumna krvi in začetne vrednosti hematokrita.
NeoRecormon contains up to 40 mg benzyl alcohol as a preservative per solvent ampoule and must therefore not be given to infants or young children up to three years old.
Zdravilo NeoRecormon vsebuje do 40 mg konzervansa benzilalkohola na ampulo vehikla in se zato ne sme dajati dojenčkom in majhnim otrokom do 3 let.
Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients.
Pri bolnikih z rakom je treba število trombocitov in raven hemoglobina tudi nadzorovati v rednih časovnih presledkih.
If you forget to use NeoRecormon
Če ste pozabili vzeti zdravilo NeoRecormon
Traceability of NeoRecormon
Sledljivost zdravila NeoRecormon
Your doctor may treat the high blood pressure with drugs.
Zdravnik vam bo lahko zdravil visok krvni tlak z zdravili.
· Very rarely (may affect up to 1 in 10,000 people) a severe form of allergic reaction has occurred, especially just after an injection.
• Zelo redko (pojavijo se lahko pri največ 1 od 10.000 bolnikov) se je, še posebno takoj po injekciji, pojavila huda oblika alergijske reakcije.
NeoRecormon can be injected under the skin in the abdomen, arm or thigh; or into a vein.
Zdravilo NeoRecormon se lahko injicira pod kožo: v trebuh, roko ali stegno, lahko pa tudi v veno.
Your doctor may do regular blood tests to check: · your potassium level.
Zdravnik bo morda redno opravljal krvne preiskave, da bo preveril:
Phenylalanine (up to 5.0 mg/vial) Sodium (less than 1 mmol per dose) Benzyl alcohol (up to 40 mg per multidose solvent ampoule)
Pomožne snovi z znanim učinkom fenilalanin (do 5,0 mg na vialo), natrij (manj kot 1 mmol na odmerek), benzilalkohol (do 40 mg na večodmerno ampulo vehikla).
9 Clean the skin above the injection port with an alcohol swab and let dry.
9 Očistite kožo nad injekcijskim dostopom z alkoholnim zložencem in pustite, da se posuši.
From a microbiological point of view, once opened, the reconstituted solution may be stored for maximum of one month at 2°C - 8°C.
Z mikrobiološkega stališča se že odprta pripravljena raztopina lahko shranjuje največ en mesec pri 2-8 °C.
The maximum dose should not exceed 1600 IU/kg body weight per week for intravenous or 1200 IU/kg per week for subcutaneous administration.
Največji odmerek pri intravenskem dajanju ne sme preseči 1600 i.e./kg telesne mase na teden, pri subkutanem dajanju pa ne 1200 i.e./kg na teden.
NeoRecormon is a clear, colourless solution for injection under the skin (subcutaneously) or into a vein (intravenously).
Zdravilo NeoRecormon je bistra brezbarvna raztopina za injiciranje pod kožo (subkutano) ali v veno (intravensko).
An individual patient data based meta-analysis, which included data from all 12 controlled clinical studies in anaemic cancer patients conducted with NeoRecormon (n=2301), showed an overall hazard ratio point estimate for survival of 1.13 in favour of controls (95 % CI 0.87, 1.46).
Meta analiza podatkov posameznih bolnikov, v katero so bili vključeni podatki iz vseh 12 kontroliranih kliničnih študij, izvedenih z zdravilom NeoRecormon pri bolnikih z rakom, ki so imeli anemijo (n = 2301), je pokazala, da je ocena celokupnega razmerja ogroženosti za preživetje 1,13 v prid kontrolni skupini (95-% interval zaupanja 0,87; 1,46).
It acts as a mitosis stimulating factor and differentiation hormone Epoetin beta, the active substance of NeoRecormon, is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anaemic patients.
Epoetin beta, zdravilno učinkovino zdravila NeoRecormon, sestavljajo iste aminokisline in ogljikovi hidrati kot eritropoetin, ki je bil izoliran iz urina anemičnih bolnikov.
In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture.
Bolnikom z visokim krvnim tlakom ali srčnožilnimi boleznimi, boleznimi možganskih ali perifernih žil moramo tedensko povečanje koncentracije hemoglobina in njegovo ciljno koncentracijo določati individualno in upoštevati klinično sliko.
· Very rarely (may affect up to 1 in 10,000 people), patients have had rising levels of potassium or phosphates in the blood.
• Zelo redko (pojavijo se lahko pri največ 1 od 10.000 bolnikov) so se pojavile povečane koncentracije kalija ali fosfatov v krvi.
Premature infants A fall in serum ferritin values is very common (see section 4.4).
Nedonošenčki Padec feritina v serumu je zelo pogost (glejte poglavje 4.4).
Colourless, clear to slightly opalescent solution.
Brezbarvna, bistra do rahlo opalescenčna raztopina.
(3) Remove the needle cover and insert the needle through the rubber seal of the device.
(3) Odstranite igelno zaščito in potisnite iglo skozi gumijast pokrov pripomočka.
It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy.
Prvih 8 tednov zdravljenja je priporočljivo redno nadzorovanje števila trombocitov.
Men:
Moški:
Erythropoietin is a growth factor that primarily stimulates red cell production.
Eritropoetin je rastni dejavnik, ki primarno stimulira nastajanje rdečih krvnih celic.
Anaemic patients with chronic renal failure
Anemični bolniki s kronično ledvično boleznijo
Therapy with NeoRecormon should be initiated by physicians experienced in the above mentioned indications.
Zdravljenje z zdravilom NeoRecormon smejo odrediti le zdravniki z izkušnjami pri naštetih indikacijah za zdravljenje.
· 1 puncture-resistant container or sharps container for safe disposal of rubber cap, needle cap and used syringe.
• 1 vsebnik za odpadne ostre predmete, za varno odstranjevanje gumijastega pokrovčka, pokrovčka injekcijske igle in uporabljene injekcijske brizge.
The initial dosage is 3 x 40 IU/kg per week.
Začetni odmerek znaša 3 x 40 i.e./kg na teden.
· Keep your syringe out of direct sunlight.
• Injekcijske brizge ne izpostavljajte neposredni sončni svetlobi.
If any of these apply to you, or might apply, tell your doctor.
Če se kar koli izmed naštetega nanaša ali bi se lahko nanašalo na vas, se posvetujte z zdravnikom.
NeoRecormon in pre-filled syringe is a sterile but unpreserved product.
Napolnjena injekcijska brizga zdravila NeoRecormon je sterilen, vendar nekonzerviran pripravek.
· Remove the needle from its blister.
• Odstranite iglo iz pretisnega omota.
The indication for treatment with NeoRecormon of nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
Pri bolnikih z nefrosklerozo, ki se še ne zdravijo z dializo, moramo indikacijo za zdravljenje z zdravilom NeoRecormon določati individualno, ker morebitnega progresivnega razvoja ledvične odpovedi ni mogoče z gotovostjo izključiti.
Remark: If you have a multipack, put the carton with the remaining syringe(s) and needle(s) back into the refrigerator
Opomba: Če imate skupno pakiranje, ga s preostalo injekcijsko brizgo ali injekcijskimi brizgami in injekcijsko iglo ali injekcijskimi iglami shranite nazaj v hladilnik.
Additional side effects in people with chronic kidney disease (renal anaemia) · Increase in blood pressure, worsening of existing high blood pressure and headache are the most common side effects (very common may affect more than 1 in 10 people).
• Zvišanje krvnega tlaka, poslabšanje obstoječega zvišanega krvnega tlaka in glavobol so najpogostejši neželeni učinki (zelo pogosti - pojavijo se lahko pri več kot 1 od 10 bolnikov).
In patients treated with NeoRecormon, this incidence is 7 % compared to 4 % in controls; this is not associated with any increase in thromboembolic mortality compared with controls.
Pri bolnikih, zdravljenih z zdravilom NeoRecormon, je bila incidenca 7-% v primerjavi s 4-% v kontrolni skupini.
Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.
Injiciramo lahko le raztopine, ki so bistre ali rahlo opalescenčne, brezbarvne in brez vidnih delcev.
· Store in a refrigerator (2°C - 8°C).
• Shranjujte v hladilniku (2-8 °C).
Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Iglo hitro izvlecite in s suho, sterilno blazinico pritisnite na mesto injiciranja.
After dissolving, NeoRecormon is injected under the skin (subcutaneously) or into a vein (intravenously).
Po raztopitvi injiciramo zdravilo NeoRecormon pod kožo (subkutano) ali v veno (intravensko).
In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and
Pri bolnikih s slabim odzivom hemoglobina na epoetine je treba razmisliti o drugih razlagah za slab odziv (glejte poglavji 4.2 in 5.1).
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).
Razlike v koncentraciji hemoglobina urejamo z uravnavanjem odmerkov, pri čemer upoštevamo, da je ciljno območje koncentracije hemoglobina od 10 g/dl (6,2 mmol/l) do 12 g/dl (7,5 mmol/l).
In patients in an autologous blood predonation programme there may be an increase in platelet count, mostly within the normal range.
Pri bolnikih, ki sodelujejo v programu avtolognega darovanja krvi, lahko pride do povečanja števila trombocitov, ki pa večinoma ne prekorači referenčnega območja.
For subcutaneous injection, clean the skin at the site of injection using an alcohol wipe.
Za subkutano injekcijo mesto injiciranja na koži očistite z alkoholom.
NeoRecormon Multidose contains benzyl alcohol as a preservative and must therefore not be given to infants or young children up to three years old.
NeoRecormon večodmerna raztopina za injiciranje vsebuje konzervans benzilalkohol, zato ga pri novorojenčkih in otrocih do tretjega leta starosti ne smemo dajati.
There may be an increase in blood pressure which can be treated with drugs.
Lahko pride do zvišanja krvnega tlaka, ki pa ga lahko nadzorujemo z zdravili.
In case anti-erythropoietin antibody-mediated PRCA is diagnosed, therapy with NeoRecormon must be discontinued and patients should not be switched to another erythropoietic protein (see section 4.4).
V primeru diagnoze čiste aplazije rdečih krvnih celic (PRCA), posredovane s protitelesi proti eritropoetinu, je treba zdravljenje z zdravilom NeoRecormon prekiniti, bolnikom pa se ne sme uvesti zdravljenja z drugim eritropoetskim proteinom (glejte poglavje 4.4).
A rise in haemoglobin of greater than 2 g/dl (1.25 mmol/l) over a four week period should be avoided.
Povečanju koncentracije hemoglobina za več kot 2 g/dl (1,25 mmol/l) v štirih tednih se je treba izogibati.