natgillin/translations-raw huggingface dataset:
Increases in some liver enzymes have also been noted in blood samples from patients being treated with Epivir.
Pri bolnikih, ki so se zdravili z Epivirjem so v krvnih vzorcih opazili tudi povečano aktivnost nekaterih jetrnih encimov.
Cases of a condition called lactic acidosis, which is a build up of lactic acid in the body, that can cause dehydration and coma have been reported on rare occasions in patients taking NRTIs (see Take special care with Epivir for more information).
Pri bolnikih, ki so jemali NRTI- je so v redkih primerih poročali o laktacidozi, stanju, ko se v telesu kopiči mlečna kislina, kar lahko povzroči komo in dehidracijo (za več informacij glejte poglavje Bodite posebno pozorni pri jemanju zdravila Epivir).
Discard one month after first opening.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Do not store above 25oC.
Shranjujte pri temperaturi do 25 ºC!
66 6.
68 6.
Epivir oral solution contains 10 mg of lamivudine in each ml of solution.
En mililiter Epivir peroralne raztopine vsebuje 10 mg lamivudina.
The oral solution also contains the following other ingredients: sugar (sucrose 3 g/ 15 ml), methyl parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, propylene glycol, water, artificial strawberry and banana flavourings.
Peroralna raztopina vsebuje tudi naslednje pomožne snovi: sladkor (saharoza 3 g/ 15 ml), metilparahidroksibenzoat, propilparahidroksibenzoat, brezvodno citronsko kislino, natrijev citrat, propilenglikol, vodo, umetno aromo jagode in umetno aromo banane.
What Epivir looks like and the contents of the pack Epivir oral solution is supplied in a white polyethylene bottle containing 240 ml of solution.
Izgled zdravila Epivir in vsebina pakiranja Epivir peroralna raztopina je na voljo v polietilenskih plastenkah, ki vsebujejo 240 ml raztopine.
An oral dosing syringe and a plastic adapter for the bottle is included in the pack.
V škatlici sta priložena tudi peroralna odmerna brizga in plastični nastavek.
Glaxo Group Ltd, Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom
Glaxo Group Ltd, Greenford Road, Greenford, Middlesex UB6 0NN, Velika Britanija
KG, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
KG, Industriestrasse 32- 36, 23843 Bad Oldesloe, Nemčija
67 For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
69 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Tel: + 39 (0)45 9218 111
70 Suomi/ Finland Italia GlaxoSmithKline Oy GlaxoSmithKline S. p. A.
Do not take Epivir:
Ne jemljite zdravila Epivir
70 Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
72 Pri bolnikih, ki prejemajo kombinacijo protiretrovirusnih zdravil, se lahko pojavi prerazdelitev, kopičenje ali izgubljanje telesnega maščevja.
Breast-feeding Since lamivudine and the virus pass into breast milk it is recommended that mothers taking Epivir do not breast-feed their infants.
73 Dojenje Ker lamivudin in virus prehajata v materino mleko je priporočljivo, da matere, ki jemljejo Epivir ne dojijo.
Swallow Epivir tablets with water or another drink.
Tablete Epivir pogoltnite cele z vodo ali drugo tekočino.
The tablets can be taken with or without food.
Lahko jih jemljete skupaj s hrano ali brez nje.
An oral solution is also available for the treatment of children over three months of age and for patients unable to take tablets or who need a lower dose.
Za zdravljenje otrok, starejših od treh mesecev, in bolnikov, ki tablet ne morejo jemati, ali potrebujejo nižji odmerek, je zdravilo Epivir na voljo tudi v obliki peroralne raztopine.
If you cannot swallow the tablet(s), you may crush and combine them with a small amount of food or drink, and take all the dose immediately.
Če tablete (tablet) ne morete pogoltniti, lahko tableto (tablete) zdrobite in dodate v manjšo količino redkega živila ali hrane, ter nato takoj v celoti zaužijte.
Increases in some liver enzymes have also been noted in blood samples from patients being treated with Epivir.
Pri bolnikih, ki so se zdravili z Epivirjem, so v krvnih vzorcih opazili tudi povečano aktivnost nekaterih jetrnih encimov.
There are rare reports (between 1 in 10,000 to 1 in 1,000 patients treated) of inflammation of the liver (hepatitis), inflammation of the pancreas (pancreatitis), breakdown of muscle tissue.
74 Redko so poročili (pri 1 izmed 10. 000 do 1 izmed 1. 000 zdravljenih bolnikov) o vnetju jeter (hepatitisu), vnetju trebušne slinavke (pankreatitisu) in razpadu mišičnega tkiva.
Cases of a condition called lactic acidosis, which is a build up of lactic acid in the body, that can cause dehydration and coma have been reported on rare occasions in patients taking NRTIs (see Take special care with Epivir for more information).
Pri bolnikih, ki so jemali NRTI- je, so v redkih primerih poročali o laktacidozi, stanju, ko se v telesu kopiči mlečna kislina, kar lahko povzroči komo in dehidracijo (za več informacij glejte poglavje Bodite posebno pozorni pri jemanju zdravila Epivir).
72 Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Kombinirano zdravljenje s protiretrovirusnimi zdravili lahko povzroči spremembe v obliki telesa zaradi sprememb v porazdelitvi maščevja.
Each Epivir film-coated tablet contains 300 mg of lamivudine.
Ena Epivir filmsko obložena tableta vsebuje 300 mg lamivudina.
Tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate Film-coat: hypromellose, titanium dioxide, black iron oxide (E172), macrogol, polysorbate 80
Filmska obloga: hipromeloza, titanov dioksid, črni železov oksid (E172), makrogol in polisorbat 80.
What Epivir looks like and the contents of the pack Epivir 300 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 30 tablets.
Izgled zdravila Epivir in vsebina pakiranja Epivir 300 mg filmsko obložene tablete so na voljo v belih polietilenskih plastenkah ali pretisnih omotih, ki vsebujejo 30 tablet.
They are grey, diamond shaped film-coated tablets, marked with the code ‘ GXEJ7’ on one side.
Na eni strani imajo oznako ‘ GXEJ7 ’.
Marketing Authorisation Holder and Manufacturer
75 Imetnik dovoljenja za promet z zdravilom in izdelovalec
Grunwaldzka 189
Grunwaldzka 189 60- 322 Poznan Poljska
For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
76 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Tel: + 421 (0)2 49 10 33 11
Tel: + 421 (0) 2 49 10 33 11 Simi: + 354 530 3700 recepcia. sk@ gsk. com
Tel: + 39 (0)45 9218 111
77 Suomi/ Finland Italia GlaxoSmithKline Oy GlaxoSmithKline S. p. A.
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Kidney Disease (CKD) is increased with the subcutaneous (sc) route. • There is insufficient data on Epoetin alfa HEXAL to know the size of any increased immunogenicity risk with sc use • Therefore, the sc route is not recommended for patients with CKD • The loss of efficacy or other symptoms of the development of immunogenicity should be investigated • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Izobraževalna brošura mora vsebovati naslednje ključne elemente: • Uporaba zdravil z epoteinom alfa lahko povzroči imunogenost, ki lahko v redkih primerih povzroči čisto aplastično anemijo (Pure Red Cell Aplasia – PRCA). • Pri drugih zdravilih, ki vsebujejo epotein, je tveganje za pojav imunogenosti pri kronični ledvični bolezni (KLB) povečano pri uporabi subkutane (s. c.) poti odmerjanja. • Podatkov o zdravilu Epoetin alfa HEXAL je premalo, da bi vedeli, za koliko se poveča tveganje za pojav imunogenosti pri subkutani uporabi zdravila. • Subkutana pot odmerjanja zato ni priporočena za bolnike s KLB. • Treba je raziskati izgubo učinkovitosti ali druge simptome pojava imunogenosti. • Vse primere suma čiste aplastične anemije ali pojava imunogenosti je treba sporočiti imetniku dovoljenja za promet z zdravilom.
Epoetin Alfa Hexal is a ‘ biosimilar’ medicine.
Zdravilo Epoetin Alfa Hexal je „ podobno biološko “ zdravilo.
This means that Epoetin Alfa Hexal is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
To pomeni, da je zdravilo Epoetin Alfa Hexal podobno biološkemu zdravilu, ki je v Evropski uniji (EU) že odobreno in vsebuje isto zdravilno učinkovino (znano tudi kot „ referenčno zdravilo “).
The reference medicine for Epoetin Alfa Hexal is Eprex/ Erypo.
Referenčno zdravilo za Epoetin Alfa Hexal je zdravilo Eprex/ Erypo.
What is Epoetin Alfa Hexal used for?
Za kaj se zdravilo Epoetin Alfa Hexal uporablja?
Epoetin Alfa Hexal is used in the following situations: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘ chronic renal failure’ (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems; • to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions; • to increase the amount of blood that can be taken in adult patients with moderate anaemia who are going to have an operation and donate their own blood before surgery (autologous blood transfusion); • to reduce the need for blood transfusions in adults with mild anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery.
Zdravilo Epoetin Alfa Hexal se uporablja v naslednji primerih: • za zdravljenje anemije (majhno število rdečih krvnih celic), ki povzroča simptome pri bolnikih s kronično odpovedjo ledvic (dolgotrajno in napredujoče upadanje sposobnosti ledvic za pravilno delovanje) ali drugimi težavami z ledvicami; • za zdravljenje anemije pri odraslih, pri katerih s kemoterapijo zdravijo določene vrste raka, in za zmanjšanje potrebe po transfuziji krvi; • za povečanje količine krvi, ki jo je mogoče odvzeti odraslim bolnikom z zmerno anemijo, ki bodo imeli kirurški poseg in pred operacijo darujejo lastno kri (avtologna transfuzija krvi); • za zmanjšanje potrebe po transfuziji krvi pri odraslih z blago obliko anemije pred zahtevnejšo ortopedsko operacijo (operacijo na kosteh), kakršna je operacija kolkov.
For patients with kidney problems and patients who are going to donate their own blood, Epoetin Alfa Hexal must be injected into a vein.
Zdravilo Epoetin Alfa Hexal je treba pri bolnikih s težavami z ledvicami in tistih, ki bodo darovali lastno kri, vbrizgati v veno.
Patients receiving chemotherapy or about to undergo orthopaedic
Bolniki, ki prejemajo kemoterapijo ali so tik pred ortopedsko operacijo, pa ga morajo prejeti podkožno.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Odmerek, pogostost injekcij in trajanje 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Epoetin Alfa Hexal can be injected under the skin by the patient or their carer if they have been trained appropriately.
Reproduction is authorised provided the source is acknowledged. uporabe zdravila so odvisni od razloga za uporabo zdravila Epoetin Alfa Hexal in jih je treba prilagoditi odzivu bolnika.
For these patients, the lowest does that provides adequate control of symptoms should be used.
Pri teh bolnikih je treba uporabiti najnižji odmerek, ki zagotavlja ustrezni nadzor nad simptomi.
The active substance in Epoetin Alfa Hexal, epoetin alfa, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Zdravilna učinkovina v zdravilu Epoetin Alfa Hexal, epoetin alfa, je kopija človeškega eritropoetina in spodbuja tvorjenje rdečih krvnih celic povsem enako kot naravni hormon.
The epoetin alfa in Epoetin Alfa Hexal is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin alfa.
Epoetin alfa v zdravilu Epoetin Alfa Hexal se proizvaja z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri celica prejme gen (DNK), s katerim lahko tvori epoetin alfa.
Epoetin Alfa Hexal was studied to show that it is comparable with the reference medicine, Eprex/ Erypo, in experimental models and in humans.
Zdravilo Epoetin Alfa Hexal so raziskovali na poskusnih modelih in pri ljudeh, da bi dokazali njegovo primerljivost z referenčnim zdravilom Eprex/ Erypo.
Epoetin Alfa Hexal, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
V eni izmed glavnih študij, ki je vključevala 479 bolnikov z anemijo, povezano z boleznijo ledvic, so primerjali vbrizgavanje zdravila Epoetin Alfa Hexal v veno in referenčno zdravilo.
All of the patients had been taking Eprex/ Erypo injected into a vein for at least eight weeks before they were either switched to Epoetin Alfa Hexal or remained on Eprex/ Erypo.
Vsem bolnikom so zdravilo Eprex/ Erypo vbrizgavali v veno vsaj osem tednov, preden so bodisi začeli prejemati zdravilo Epoetin Alfa Hexal ali pa so še naprej prejemali zdravilo Eprex/ Erypo.
The company also presented the results of a study comparing the effects of Epoetin Alfa Hexal injected under the skin with those of Eprex/ Erypo in 114 cancer patients who were receiving chemotherapy.
Družba je predstavila tudi rezultate študije, v kateri so pri 114 bolnikih z rakom, ki so se zdravili s kemoterapijo, učinke podkožnega dajanja zdravila Epoetin Alfa Hexal primerjali z zdravilom Eprex/ Erypo.
Epoetin Alfa Hexal was as effective as Eprex/ Erypo in increasing and maintaining red blood cell counts.
Zdravilo Epoetin Alfa Hexal je bilo pri zviševanju in vzdrževanju števila rdečih krvnih celic enako učinkovito kot zdravilo Eprex/ Erypo.
In the study of patients with anaemia caused by kidney problems, patients switching to Epoetin Alfa Hexal maintained haemoglobin levels to the same extent as those continuing to take Eprex/ Erypo.
V študiji pri bolnikih z anemijo, ki jo povzroča bolezen ledvic, so bile ravni hemoglobina pri bolnikih, ki so začeli prejemati zdravilo Epoetin Alfa Hexal, enako dobro vzdrževane kot pri tistih, ki so še naprej prejemali zdravilo Eprex/ Erypo.
On average, the levels of the patients taking Epoetin Alfa Hexal increased by 0.147 g/ dl from a starting value of 11.7 g/ dl.
Pri bolnikih, ki so prejemali zdravilo Epoetin Alfa Hexal, so se ravni v povprečju zvišale za 0, 147 g/ dl glede na začetno vrednost, ki je znašala 11, 7 g/ dl.
The study in patients receiving chemotherapy showed that Epoetin Alfa Hexal was also as effective as Eprex/ Erypo when it was injected under the skin.
Študija pri bolnikih, ki so se zdravili s kemoterapijo, je pokazala, da je bilo podkožno vbrizgavanje zdravila Epoetin Alfa Hexal enako učinkovito kot podkožno vbrizgavanje zdravila Eprex/ Erypo.
The most common side effect with Epoetin Alfa Hexal is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden, stabbing migraine- like headache and confusion.
Najpogostejši neželeni učinki zdravila Epoetin Alfa Hexal so povišan krvni tlak, ki lahko včasih povzroči simptome encefalopatije (zapletov v možganih), kakršni so nenadni, migrenam podobni glavoboli z ostro bolečino in zmedenost.
Epoetin Alfa Hexal can also lead to skin rash and flu-like symptoms.
Zdravilo Epoetin Alfa Hexal lahko povzroči tudi kožne izpuščaje in gripi podobne simptome.
For the full list of all side effects reported with Epoetin Alfa Hexal, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Epoetin Alfa Hexal, glejte navodilo za uporabo.
Epoetin Alfa Hexal should not be used in people who may be hypersensitive (allergic) to epoetin alfa or any of the other ingredients.
Zdravila Epoetin Alfa Hexal ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin alfa ali katero koli drugo sestavino zdravila.
It must not be used in the following groups:
Prav tako ga ne smejo uporabljati naslednje skupine bolnikov:
2/ 3 • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin; • patients with high blood pressure that is not controlled; • patients who are going to donate their own blood who have had a heart attack of stroke within the last month, who have angina pectoris (a severe type of chest pain) or who are at risk of deep venous thrombosis (DVT: formation of blood clots in the deep veins of the body, usually in the leg); • patients who cannot receive medicines for the prevention of blood clots; • patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
2/ 3 • bolniki, pri katerih se razvije aplazija rdečih krvnih celic (zmanjšano ali zaustavljeno tvorjenje rdečih krvnih celic), ki se pojavi po zdravljenju z eritropoetinom; • bolniki z nenadzorovanim visokim krvnim tlakom; • bolniki, ki bodo darovali lastno kri in ki so imeli srčni infarkt ali možgansko kap v zadnjem mesecu, imajo angino pektoris (hudo vrsto bolečine v prsih) ali pri katerih obstaja tveganje za nastanek globoke venske tromboze (DVT: nastanek krvnih strdkov v globokih venah telesa, običajno v nogi); • bolniki, ki ne smejo jemati zdravil za preprečevanje nastajanja krvnih strdkov; • bolniki, ki so tik pred zahtevnejšo ortopedsko operacijo in imajo resne kardiovaskularne (srčno - žilne) težave, vključno z nedavnim srčnim infarktom ali možgansko kapjo.
Epoetin Alfa Hexal is not recommended for injection under the skin in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.
Podkožno vbrizgavanje zdravila Epoetin Alfa Hexal ni priporočeno za zdravljenje težav z ledvicami, ker so potrebne še nadaljnje študije za pridobitev zagotovila, da tak način zdravljenja ne povzroča alergičnih reakcij.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Epoetin Alfa Hexal has been shown to have a comparable quality, safety and efficacy profile to Eprex/ Erypo.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so v skladu z zahtevami EU uspeli dokazati kakovost, varnost in učinkovitost zdravila Epoetin Alfa Hexal, ki je primerljiva z zdravilom Eprex/ Erypo.
The Committee recommended that Epoetin Alfa Hexal be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Epoetin Alfa Hexal odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Epoetin Alfa Hexal?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Epoetin Alfa Hexal?
The company that makes Epoetin Alfa Hexal will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
Družba, ki izdeluje zdravilo Epoetin Alfa Hexal, bo za zdravstvene delavce v vseh državah članicah priskrbela informativne pakete, ki bodo vključevali tudi informacije o varnosti zdravila.
Other information about Epoetin Alfa Hexal:
Druge informacije o zdravilu Epoetin Alfa Hexal:
The European Commission granted a marketing authorisation valid throughout the EU for Epoetin Alfa Hexal to Hexal AG on 28 August 2007.
Evropska komisija je dovoljenje za promet z zdravilom Epoetin Alfa Hexal, veljavno po vsej Evropski uniji, odobrila družbi Hexal AG dne 28. avgusta 2007.
The full EPAR for Epoetin Alfa Hexal can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Epoetin Alfa Hexal je na voljo tukaj.
8000 IU/ 0.8 ml
8000 I. E. / 0, 8 ml
0.8 ml (10000 IU/ ml)
0, 8 ml (10000 I. E. / ml)
10000 IU/ 1.0 ml
10000 I. E. / 1, 0 ml
1.0 ml (10000 IU/ ml)
1, 0 ml (10000 I. E. / ml)
7000 IU/ 0.7 ml
7000 I. E. / 0, 7 ml
0.7 ml (10000 IU/ ml)
0, 7 ml (10000 I. E. / ml)
9000 IU/ 0.9 ml
9000 I. E. / 0, 9 ml
0.9 ml (10000 IU/ ml)
0, 9 ml (10000 I. E. / ml)
Epoetin alfa HEXAL 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 1. 000 i. e. / 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Epoetin alfa HEXAL can be used to increase the yield of autologous blood from patients in a predonation programme.
Zdravilo Epoetin alfa HEXAL se lahko uporablja za povečanje količine pridobljene avtologne krvi pri bolnikih v preddonorskem programu.
Epoetin alfa HEXAL can be used to reduce exposure to allogeneic blood transfusions in adult non-iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications.
Zdravilo Epoetin alfa HEXAL lahko uporabljamo za zmanjšanje izpostavljenosti alogenskim transfuzijam krvi pred večjimi elektivnimi ortopedskimi kirurškimi posegi pri odraslih bolnikih brez pomanjkanja železa, pri katerih obstaja veliko tveganje za zaplete pri transfuziji.
Epoetin alfa HEXAL should be administered intravenously in order to increase haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
Zdravilo Epoetin alfa HEXAL je treba dajati intravensko, da se koncentracija hemoglobina ne poveča na več kot 12 g/ dl (7, 5 mmol/ l).
If the haemoglobin is rising by more than 2 g/ dl (1.25 mmol/ l) per month, or if the sustained haemoglobin exceeds 12 g/ dl (7.5 mmol/ l) reduce the epoetin alfa dose by 25%.
Če se hemoglobin zviša za več kot 2 g/ dl (1. 25 mmol/ l) na mesec ali če stalna koncentracija hemoglobina preseže 12 g/ dl (7, 5 mmol/ l), zmanjšajte odmerek epoetina alfa za 25%.
Epoetin alfa HEXAL should be given by the intravenous route.
Zdravilo Epoetin alfa HEXAL je treba dati intravensko.
At the time of donating blood, Epoetin alfa HEXAL should be administered after the completion of the blood donation procedure.
V času doniranja krvi je treba zdravilo Epoetin alfa HEXAL uporabiti po tem, ko je postopek doniranja krvi končan.
Mildly anaemic patients (haematocrit of 33 - 39%) requiring predeposit of ≥ 4 units of blood should be treated with Epoetin alfa HEXAL at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
Blago anemične bolnike (hematokrit 33- 39%), ki potrebujejo ≥ 4 enote deponirane krvi, je treba zdraviti z zdravilom Epoetin alfa HEXAL pri odmerku 600 i. e. / kg telesne mase 2- krat na teden 3 tedne pred kirurškim posegom.
All patients being treated with Epoetin alfa HEXAL should receive adequate iron supplementation (e. g.
Vsi bolniki, ki prejemajo zdravilo Epoetin alfa HEXAL, morajo ves čas zdravljenja prejemati ustrezni nadomestek železa (npr.
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 Epoetin alfa HEXAL therapy.
Nadomestek železa je treba začeti jemati čim prej, celo več tednov pred začetkom avtolognega deponiranja, da se doseže zadostna količina nakopičenega železa pred začetkom zdravljenja z zdravilom Epoetin alfa HEXAL.
In chronic renal failure patients Epoetin alfa HEXAL has not to be administered subcutaneously!
Bolnikom s kronično ledvično odpovedjo se zdravilo Epoetin alfa HEXAL ne sme dajati subkutano!
Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Epoetin alfa HEXAL or any other erythropoietin (see section 4.4 - Pure Red Cell Aplasia).
Bolniki, pri katerih se po zdravljenju s katerimkoli eritropoetinom razvije aplazija rdečih krvnih celic (PRCA – Pure Red Cell Aplasia), ne smejo dobivati zdravila Epoetin alfa HEXAL ali kateregakoli drugega eritropoetina (glejte poglavje 4. 4 – Aplazija rdečih krvnih celic).
7 4.4 Special warnings and precautions for use
7 4. 4 Posebna opozorila in previdnostni ukrepi