natgillin/translations-raw huggingface dataset:
Each APTIVUS capsule contains 250 mg of the active substance tipranavir.
Ena kapsula zdravila APTIVUS vsebuje 250 mg zdravilne učinkovine tipranavirja.
APTIVUS is supplied in bottles containing 120 capsules.
Zdravilo APTIVUS je na voljo v stekleničkah po 120 kapsul.
The Marketing Authorisation Holder is:
Imetnik dovoljenja za promet z zdravilom je:
Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein Germany
Boehringer Ingelheim International GmbH Binger Strasse 173 D- 55216 Ingelheim am Rhein Germany Nemčija
The Manufacturer is:
Izdelovalec je:
KG Binger Strasse 173 D-55216 Ingelheim am Rhein Germany
KG Binger Strasse 173 D- 55216 Ingelheim am Rhein Germany Nemčija
40 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
42 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
This leaflet was last approved in {MM/ YYYY}
Navodilo je bilo odobreno {MM/ LLLL}
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.
Aranesp is a solution for injection in a vial, a pre-filled syringe or a pre-filled pen.
Zdravilo Aranesp je raztopina za injiciranje v viali, v napolnjeni injekcijski brizgi ali v napolnjenem injekcijskem peresniku.
Aranesp exists in various strengths, from 10 to 500 micrograms per millilitre.
Zdravilo Aranesp je na voljo v različnih jakostih, od 10 do 500 mikrogramov na mililiter.
See the Package Leaflet for full details.
Za več informacij glejte Navodilo za uporabo.
Aranesp is used to treat anaemia (fewer red blood cells in the blood than normal) in two groups of patients: • adults and children over one year of age with anaemia caused by long-term kidney failure, when the body does not produce enough of the natural hormone erythropoietin, • adult patients with certain types of cancer who are receiving chemotherapy (the medicines used to treat cancer), when the chemotherapy stops the bone marrow producing enough blood cells.
Zdravilo Aranesp se uporablja za zdravljenje anemije (v krvi je manj eritrocitov kot normalno) pri dveh skupinah bolnikov: • odraslih in otrocih, starih več kot eno leto, z anemijo, ki je nastala zaradi dolgotrajne ledvične odpovedi, kadar telo ne tvori dovolj naravnega hormona eritropoetina. • odraslih z določeno vrsto raka, ki prejemajo kemoterapijo (zdravila za zdravljenje raka), ko kemoterapija prepreči zadostno proizvodnjo krvnih celic v kostnem mozgu.
The types of cancer where Aranesp can be used are ‘ non-myeloid’ (do not affect the bone marrow).
Zdravilo Aranesp se lahko uporablja za „ nemieloidne “ vrste rake (tiste, ki ne prizadenejo kostnega mozga).
Aranesp treatment should be initiated by a doctor who has experience in treating either of the two types of anaemia mentioned above.
Zdravljenje z zdravilom Aranesp mora uvesti zdravnik, ki ima izkušnje z zdravljenjem katere koli izmed zgoraj navedenih anemij.
Aranesp is injected intravenously (into a vein) or subcutaneously (under the skin).
Zdravilo Aranesp se vbrizga intravensko (v žilo) ali subkutano (pod kožo).
The dose used depends on why Aranesp is used, varying from 0.45 micrograms per kilogram body weight every week (or 0.75 micrograms/ kg every other week) in adults and children with kidney failure aged 11 years or older, to 6.75 micrograms/ kg every three weeks in cancer patients.
Uporabljeni odmerek je odvisen od namena uporabe zdravila Aranesp in znaša od 0, 45 mikrogramov na kilogram vsak teden (ali 0, 75 mikrogramov/ kg vsak drugi teden) pri ledvični odpovedi pri odraslih in otrocih, starih 11 let ali več, do 6, 75 mikrogramov/ kg vsake tri tedne pri bolnikih z rakom.
Doses and dose frequency (how often Aranesp is given) are adjusted depending on the response.
Odmerki in frekvenca odmerjanja (pogostost uporabe zdravila Aranesp) so prilagojeni odzivu organizma.
Aranesp is supplied ready for use in a pre-filled syringe or pre-filled pen, which can be used by the patient or their carer.
Zdravilo Aranesp je na voljo za uporabo v napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku, ki ju lahko uporabi bolnik ali njegov negovalec.
Darbepoetin alfa is 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Darbepoetin alfa, zdravilna učinkovina zdravila Aranesp, deluje natanko tako kot naravni eritropoetin, ki ga proizvaja 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 produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes the cell able to produce darbepoetin alfa.
(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 telo, vendar pa majhna razlika v njegovi strukturi pomeni, da darbepoetin alfa učinkuje dlje in se tako lahko daje manj pogosto kot naravni eritropoetin.
In patients with long-term kidney failure, the main cause of their anaemia is a lack of natural erythropoietin.
Darbepoetin alfa je izdelan z metodo, imenovano „ rekombinantna DNA tehnologija “: proizvede ga celica, ki je prejela gen (DNA), ki ji omogoča tvorbo darbepoetina alfa.
Aranesp works by stimulating the production of red blood cells in the same way as natural erythropoietin.
Zdravilo Aranesp deluje tako, da stimulira tvorbo eritrocitov na enak način kot naravni eritropoetin.
The effectiveness of Aranesp has been studied in patients with long-term kidney disease, where it was compared with recombinant human erythropoietin in four studies involving over 1,200 patients, and in patients receiving chemotherapy for cancer such as lung cancer, myeloma or lymphoma, where it was compared with placebo (a dummy treatment) in two studies involving 669 patients.
Učinek zdravila Aranesp so preučevali pri bolnikih z dolgotrajnim ledvičnim obolenjem, kjer so ga v štirih študijah, ki so vključevale več kot 1200 bolnikov, primerjali z rekombinantnim humanim eritropoetinom, preučevali pa so ga tudi pri bolnikih, ki prejemajo kemoterapijo za zdravljenje raka, kot je rak na pljučih, mielom ali limfom, kjer so ga v dveh študijah, ki sta vključevali 669 bolnikov, primerjali s placebom (zdravilom brez zdravilne učinkovine).
Aranesp has also been studied in 124 children with long-term kidney disease to check that it is absorbed in the same way as in adults.
Zdravilo Aranesp so preučevali tudi pri 124 otrocih z dolgotrajnim ledvičnim obolenjem, kjer so ugotavljali, ali se absorbira na enak način kot pri odraslih.
What benefit has Aranesp shown during the studies?
Kakšne koristi je zdravilo Aranesp izkazalo med raziskavami?
Aranesp was as effective as human recombinant erythropoietin at increasing the haemoglobin levels in patients with kidney disease, and at keeping these levels maintained after they had been improved, whether given as an intravenous or subcutaneous injection.
Tako pri intravenskem kot pri subkutanem dajanju je bilo zdravilo Aranesp pri zviševanju koncentracije hemoglobina pri bolnikih z obolenjem ledvic in pri ohranjanju dosežene koncentracije tako učinkovito kot humani rekombinantni eritropoetin.
In cancer patients receiving chemotherapy, fewer patients treated with Aranesp needed a blood transfusion compared with those given placebo.
Pri bolnikih z rakom, ki so prejemali kemoterapijo, je transfuzijo krvi potrebovalo manj bolnikov, zdravljenih z zdravilom Aranesp, v primerjavi s tistimi bolniki, ki so prejemali placebo.
The most common side effects with Aranesp (seen in between 1 and 10 patients in 100) are headache, hypertension (high blood pressure), thrombosis (blood clots), injection site pain, arthralgia (joint pain) and peripheral oedema (fluid retention).
Najpogostejši neželeni učinki zdravila Aranesp (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol, hipertenzija (visok krvni tlak), tromboza (krvni strdki), bolečina na mestu vboda, artralgija (bolečina v sklepih) in periferni edem (zastajanje tekočine).
For the full list of all side effects reported with Aranesp, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Aranesp, glejte Navodilo za uporabo.
Aranesp should not be used in people who may be hypersensitive (allergic) to darbepoetin alfa or any of the other ingredients, or in patients who have poorly controlled high blood pressure.
Zdravila Aranesp se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) darbepoetin alfa ali na katerokoli drugo sestavino zdravila ali pri bolnikih s slabo nadzorovanim visokim krvnim pritiskom.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aranesp’ s benefits are greater than its risks for the treatment of anaemia associated with chronic renal failure in adults and paediatric patients, and of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Aranesp pri zdravljenju anemije, povezane s kronično odpovedjo ledvic pri odraslih in pediatričnih bolnikih, in simptomatske anemije pri odraslih onkoloških bolnikih z nemieloidnimi malignomi, ki prejemajo kemoterapijo, večje od z njim povezanih tveganj.
The Committee recommended that Aranesp be given marketing authorisation.
Odbor je zato je priporočil, da se za zdravilo Aranesp odobri dovoljenje za promet.
Other information about Aranesp:
Druge informacije o zdravilu Aranesp:
The European Commission granted a marketing authorisation valid throughout the European Union for Aranesp to Amgen Europe B. V. on 8 June 2001.
Evropska komisija je dovoljenje za promet z zdravilom Aranesp, veljavno po vsej Evropski uniji, odobrila družbi Dompé Biotec S. p. A. dne 8. junija 2001.
The marketing authorisation was renewed on 8 June 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano 8. junija 2006.
The full EPAR for Aranesp is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Aranesp je na voljo tukaj.
This summary was last updated in 09-2007.
Povzetek je bil nazadnje posodobljen 09- 2007.
Subcutaneous or intravenous use
Za subkutano ali intravensko uporabo
4 pre-filled syringe
4 napolnjene brizge
1 pre-filled syringe (non- blister)
1 napolnjena brizga (v nepretisni ovojnini)
pre-filled pen (glass) (SureClick)
(stekleni) napolnjeni injekcijski peresnik (SureClick)
Subcutaneous or intravenous use
Za subkutano uporabo
pre-filled pen (glass)
(stekleni) napolnjeni injekcijski peresnik (SureClick)
4/ 4
6/ 7 7/ 7
Aranesp 10 micrograms solution for injection in a pre-filled syringe.
Aranesp 10 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi.
Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 ml (25 µg/ ml).
Ena napolnjena injekcijska brizga vsebuje 10 mikrogramov darbepoetina alfa v 0, 4 ml (25 µg/ ml).
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Darbepoetin alfa je pridobljen z gensko tehnologijo v ovarijskih celicah kitajskega hrčka (CHO- K1).
For excipients, see section 6.1.
Za pomožne snovi glejte poglavje 6. 1.
Aranesp treatment should be initiated by physicians experienced in the above mentioned indications.
Zdravljenje z Aranespom mora uvesti zdravnik, ki ima izkušnje z navedenima indikacijama.
Aranesp is supplied ready for use in a pre-filled syringe.
Aranesp je na voljo pripravljen za uporabo v napolnjeni injekcijski brizgi.
The instructions for use, handling and disposal are given in section 6.6.
Navodila za uporabo, ravnanje z zdravilom in odlaganje so navedena v poglavju 6. 6.
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; zdravnik mora oceniti klinični potek in stanje pri posameznem bolniku.
Aranesp should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
Cilj je zvišanje hemoglobina na ne več kot 120 g/ l (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).
Variabilnosti hemoglobina se je treba prilagoditi z uravnavanjem odmerka, pri čemer je treba upoštevati ciljno območje koncentracije hemoglobina od 100 g/ l (6, 2 mmol/ l) do 120 g/ l (7, 5 mmol/ l).
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.
Smernice za prilagoditev odmerka, če hemoglobin preseže 120 g/ l (7, 5 mmol/ l), so navedene spodaj.
A rise in haemoglobin of greater than 2 g/ dl (1.25 mmol/ l) over a four week period should be avoided.
Izogniti se je treba zvišanju koncentracije hemoglobina, večjemu od 20 g/ l (1, 25 mmol/ l) v štirih tednih.
Treatment with Aranesp is divided into two stages – correction and maintenance phase.
Zdravljenje z Aranespom delimo na dve obdobji – obdobje korekcije in obdobje vzdrževanja.
2 Adult patients with chronic renal failure
2 Odrasli bolniki s kronično odpovedjo ledvic
The initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly.
Začetni subkutani ali intravenski odmerek je 0, 45 µg/ kg telesne mase v eni injekciji enkrat na teden.
Alternatively, in patients not on dialysis, an initial dose of 0.75 μ g/ kg may be administered subcutaneously as a single injection once every two weeks.
Pri bolnikih, ki niso na dializi, je druga možnost začetni odmerek 0, 75 μg/ kg subkutano v eni injekciji enkrat na dva tedna.
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks) increase the dose by approximately 25%.
Če se hemoglobin ne zviša dovolj (manj kot 10 g/ l (0, 6 mmol/ l) v štirih tednih), odmerek povečajte za približno 25%.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%.
Če se hemoglobin v štirih tednih zviša za več kot 20 g/ l (1, 25 mmol/ l), zmanjšajte odmerek za približno 25%, odvisno od hitrosti zvišanja.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
Če hemoglobin preseže 120 g/ l (7, 5 mmol/ l), pride v poštev zmanjšanje odmerka.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
Če se hemoglobin še naprej zvišuje, morate odmerek zmanjšati za približno 25%.
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
Če se hemoglobin po zmanjšanju odmerka še naprej zvišuje, uporabo začasno prekinite, dokler se hemoglobin ne začne zniževati; potem terapijo znova uvedite z odmerkom, približno 25% manjšim od prejšnjega.
In the maintenance phase, Aranesp may continue to be administered as a single injection once weekly or once every two weeks.
Med obdobjem vzdrževanja je mogoče Aranesp še naprej uporabljati v eni injekciji na teden ali na dva tedna.
In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Ko je z uporabo Aranespa enkrat na teden ali enkrat na dva tedna ciljni hemoglobin dosežen, je pri bolnikih, ki niso na dializi, druga možnost subkutana uporaba zdravila enkrat na mesec; začetni odmerek naj bo dvakrat tolikšen, kot ga je bolnik pred tem dobival na dva tedna.
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
Če je za ohranitev hemoglobina na želeni ravni potrebna prilagoditev odmerka, je odmerek priporočljivo prilagoditi za približno 25%.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
Če se hemoglobin v štirih tednih zviša za več kot 20 g/ l (1, 25 mmol/ l), zmanjšajte odmerek za približno 25%, odvisno od hitrosti zvišanja.
Patients should be monitored closely to ensure that the lowest approved dose of Aranesp is used to provide adequate control of the symptoms of anaemia.
Bolnike morate natančno kontrolirati in tako zagotoviti uporabo najmanjšega odobrenega odmerka Aranespa, ki je potreben za ustrezno obvladanje simptomov anemije.
Clinical studies have demonstrated that adult patients receiving r-HuEPO one, two or three times weekly may be converted to once weekly or once every other week Aranesp.
Klinične študije so pokazale, da lahko odrasli bolniki, ki dobivajo r- HuEPO enkrat, dvakrat ali trikrat na teden, preidejo na Aranesp enkrat na teden ali enkrat na dva tedna.
The initial weekly dose of Aranesp (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
Začetni tedenski odmerek Aranespa (µg/ teden) lahko določite tako, da celotni tedenski odmerek r- HuEPO (i. e. / teden) delite z 200.
Because
Začetni odmerek Aranespa na dva tedna (µg vsak drugi teden) lahko določite tako, da celotni kumulativni odmerek r- HuEPO, apliciran v dveh tednih, delite z 200.
3 of individual variability, titration to optimal therapeutic doses is expected for individual patients.
Zaradi individualne variabilnosti je treba pričakovati, da bo pri posameznem bolniku potrebno titriranje do optimalnega terapevtskega odmerka.
When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Pri zamenjavi r- HuEPO z Aranespom je treba uporabiti isto pot aplikacije, hemoglobin pa kontrolirati na en do dva tedna.
Paediatric patients with chronic renal failure
3 Pediatrični bolniki s kronično odpovedjo ledvic
For patients ≥ 11 years of age, the initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly.
Za bolnike, stare ≥ 11 let, je začetni subkutani ali intravenski odmerek 0, 45 µg / kg telesne mase v eni injekciji enkrat na teden.
Alternatively, in patients not on dialysis, an initial dose of 0.75 μ g/ kg may be administered subcutaneously as a single injection once every two weeks.
Pri bolnikih, ki niso na dializi, je druga možnost začetni odmerek 0, 75 µg/ kg subkutano v eni injekciji enkrat na dva tedna.
For paediatric patients ≥ 11 years of age, in the maintenance phase, Aranesp may continue to be administered as a single injection once weekly or once every two weeks.
Pri pediatričnih bolnikih, starih ≥ 11 let, lahko Aranesp med obdobjem vzdrževanja še naprej uporabljate v eni injekciji enkrat na teden ali enkrat na dva tedna.
Dialysis patients converting from once weekly to once every other week dosing with Aranesp should initially receive a dose equivalent to twice the previous once weekly dose.
Dializni bolniki, ki preidejo z Aranespa enkrat na teden na Aranesp enkrat vsak drugi teden, morajo uvodoma dobiti odmerek, ki ustreza dvojnemu dotedanjemu odmerku enkrat na teden.
In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Ko je z odmerjanjem enkrat na dva tedna dosežen ciljni hemoglobin, lahko bolniki, ki niso na dializi, Aranesp dobivajo subkutano enkrat na mesec; začetni odmerek naj bo dvakrat tolikšen, kot ga je bolnik pred tem dobival enkrat na dva tedna.
For pediatric patients 1-18 years of age, clinical data in paediatric patients has demonstrated that patients receiving r-HuEPO two or three times weekly may be converted to once weekly Aranesp, and those receiving r-HuEPO once weekly may be converted to once every other week Aranesp.
Za pediatrične bolnike od 1. do 18. leta starosti klinični podatki pri pediatričnih bolnikih kažejo, da lahko tisti, ki dobivajo r- HuEPO dva - ali trikrat na teden, preidejo na Aranesp enkrat na teden, tisti, ki dobivajo r- HuEPO enkrat na teden, pa na Aranesp enkrat vsak drugi teden.
The initial weekly or once every other week pediatric dose of Aranesp (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 240.
Začetni pediatrični odmerek Aranespa (µg/ teden) enkrat na teden ali enkrat vsak drugi teden lahko določite tako, da celotni tedenski odmerek r- HuEPO (i. e. / teden) delite z 240.
When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Pri zamenjavi r- HuEPO z Aranespom je treba uporabiti isto pot aplikacije, hemoglobin pa kontrolirati na en ali dva tedna.
If after a dose reduction, haemoglobin continues to
Če se hemoglobin po zmanjšanju odmerka še naprej zvišuje, uporabo začasno prekinite, dokler se hemoglobin ne začne zniževati; potem terapijo znova uvedite z odmerkom, približno 25% manjšim od prejšnjega.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
4 Po vsaki prilagoditvi odmerka ali odmerne sheme je treba koncentracijo hemoglobina spremljati na en do dva tedna.
Aranesp should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10 g/ dl (6.2 mmol/ l)) in order to increase haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
Bolniki z anemijo (npr. koncentracijo hemoglobina ≤ 100 g/ l (6, 2 mmol/ l)) morajo Aranesp dobiti subkutano s ciljem, da se hemoglobin zviša na ne več kot 120 g/ l (7, 5 mmol/ l).
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustments for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Smernice za prilagoditev odmerka, če hemoglobin preseže 120 g/ l (7, 5 mmol/ l), so navedene spodaj.
The recommended initial dose is 500 μ g (6.75μ g/ kg) given once every three weeks, or once weekly dosing can be given at 2.25 μ g/ kg body weight.
Priporočeni začetni odmerek je 500 µg (6, 75 µg/ kg) enkrat na tri tedne, uporabiti pa je mogoče tudi odmerjanje 2, 25 µg/ kg telesne mase enkrat na teden.
Aranesp therapy should be discontinued approximately four weeks after the end of chemotherapy.
Zdravljenje z Aranespom je treba končati približno 4 tedne po koncu kemoterapije.
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to ensure that the lowest approved dose of Aranesp is used to maintain haemoglobin at a level that controls the symptoms of anaemia.
Ko je terapevtski cilj pri posameznem bolniku dosežen, je treba odmerek zmanjšati za 25 do 50% in tako zagotoviti uporabo najmanjšega odobrenega odmerka Aranespa, potrebnega za vzdrževanje takšne koncentracije hemoglobina, ki obvladuje simptome anemije.
Appropriate dose titration between 500 μ g, 300 μ g, and 150 μ g should be considered.
V poštev pride ustrezno titriranje odmerka med 500 µg, 300 µg in 150 µg.
Patients should be monitored closely, if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose should be reduced by approximately 25 to 50%.
Če hemoglobin preseže 120 g/ l (7, 5 mmol/ l), morate odmerek zmanjšati za približno 25 do 50%.