natgillin/translations-raw huggingface dataset:
Complete resuspension should be ensured by mild agitation of the vial before use.
Pred uporabo z rahlim stresanjem viale zagotovite popolno resuspenzijo.
If precipitates are observed, the reconstituted suspension should be discarded.
Zavrzite rekonstituirano suspenzijo, če opazite oborine.
The exact total dosing volume of 5 mg/ml suspension required for the patient should be calculated and the appropriate amount of reconstituted Abraxane should be injected into an empty, sterile, polyvinyl chloride (PVC) type IV bag.
Izračunajte natančen celokupen volumen odmerka 5 mg/ ml suspenzije, ki ga potrebuje bolnik, nato pa ustrezno količino rekonstituiranega zdravila Abraxane injicirajte v prazno, sterilno IV vrečko, polivinilkloridnega (PVC) tipa.
In-line filters should not be used.
Ne uporabljajte notranjih filtrov[ A2].
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Pri parenteralnih zdravilih morate opraviti vizualen pregled za delce in obarvanje pred administracijo zdravila, kadar to omogočata raztopina in embalaža.
Stability Unopened vials of Abraxane are stable until the date indicated on the package when the vial is kept in the outer carton in order to protect from light.
Stabilnost Neodprte viale zdravila Abraxane so stabilne do datuma, ki je naveden na ovojnini, če vialo hranite v zunanjem kartonu zaradi zaščite pred svetlobo.
Neither freezing nor refrigeration adversely affects the stability of the product.
Na stabilnost izdelka ne vpliva niti zamrzovanje niti hlajenje.
Stability of the reconstituted suspension in the vial After first reconstitution, the suspension should be filled into an infusion bag immediately.
Stabilnost rekonstituirane suspenzije v viali Po prvi rekonstituciji morate suspenzijo takoj natočiti v infuzijsko vrečko.
Stability of the reconstituted suspension in the infusion bag After reconstitution, the reconstituted suspension in the infusion bag should be used immediately.
Stabilnost rekonstituirane suspenzije v infuzijski vrečki Po rekonstituciji morate suspenzijo v infuzijski vrečki takoj uporabiti.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UPOŠTEVATI DRŽAVE ČLANICE
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UPOŠTEVATI DRŽAVE ČLANICE
• Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling • Cool boxes for patients clearly labelled with a visual aid indicating correct use of product.
• izobraževalno brošuro; • povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje; • hladne škatle za bolnike, na katerih je jasno označen vizualni pripomoček, ki kaže pravilno uporabo zdravila.
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 Abseamed 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 Abseamed 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.
It is available in pre-filled syringes containing between 1,000 and 10,000 international units (IU) of the active substance, epoetin alfa.
Na voljo je v obliki napolnjene injekcijske brizge, ki vsebuje med 1 000 in 10 000 mednarodnih enot (i. e.) zdravilne učinkovine epoetin alfa.
Abseamed is a ‘ biosimilar’ medicine.
Zdravilo Abseamed je „ podobno biološko “ zdravilo.
This means that Abseamed 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 Abseamed 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 Abseamed is Eprex/ Erypo.
Referenčno zdravilo za Abseamed je zdravilo Eprex/ Erypo.
Abseamed 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 take 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 Abseamed 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.
The medicine can only be obtained with a prescription.
Zdravilo se uporablja pri bolnikih z normalnimi ravnmi železa, pri katerih so možni zapleti v primeru prejema transfuzije krvi, če pred operacijo nimajo možnosti darovati lastne krvi, pričakovane izgube le- te pa znašajo od 900 do 1800 ml. • Zdravilo se dobi samo na recept.
For patients with kidney problems and patients who are going to donate their own blood, Abseamed must be injected into a vein.
Zdravilo Abseamed 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 surgery receive it under the skin.
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.
Zdravilo Abseamed si lahko pod kožo injicira bolnik sam ali mu ga injicira 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. have been trained appropriately.
Reproduction is authorised provided the source is acknowledged. negovalec, če sta bila za to ustrezno usposobljena.
The dose, the frequency of injection and how long it is used for depend on why Abseamed is being used, and are adjusted according to the patient’ s response.
Odmerek, pogostost injekcij in trajanje uporabe zdravila so odvisni od razloga za uporabo zdravila Abseamed in jih je treba prilagoditi odzivu bolnika.
For patients with chronic renal failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/ dl in children).
Pri bolnikih s kronično odpovedjo ledvic ali tistih, ki prejemajo kemoterapijo, morajo ravni hemoglobina ostati v okviru priporočene vrednosti (med 10 in 12 gramov na deciliter pri odraslih in med 9, 5 in 11 g/ dl pri otrocih).
For these patients, the lowest dose that provides adequate control of symptoms should be used.
Pri teh bolnikih je treba uporabiti najnižji odmerek, ki zagotavlja ustrezni nadzor nad simptomi.
The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.
Pred zdravljenjem je treba preveriti ravni železa vseh bolnikov in s tem zagotoviti, da jim tega elementa ne bo primanjkovalo, med zdravljenjem pa morajo jemati dodatke, ki vsebujejo železo.
For full details, see the Package Leaflet.
Za podrobnosti glejte navodilo za uporabo.
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Pri bolnikih, ki prejemajo kemoterapijo, ali bolnikih s težavami z ledvicami, lahko pomanjkanje eritropoetina ali nezadostna odzivnost telesa na naravno prisoten eritropoetin povzroči anemijo.
In these cases, erythropoietin is used to replace the missing hormone or to increase red blood cell counts.
V teh primerih se eritropoetin uporablja za nadomeščanje manjkajočega hormona ali za povečanje števila rdečih krvnih celic.
Erythropoietin is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Eritropoetin se uporablja tudi pred operacijami za povečanje števila rdečih krvnih celic in kot pomoč pri manjšanju posledic izgube krvi.
The active substance in Abseamed, 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 Abseamed, epoetin alfa, je kopija človeškega eritropoetina in spodbuja tvorjenje rdečih krvnih celic povsem enako kot naravni hormon.
The epoetin alfa in Abseamed is produced by ‘ 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 Abseamed se proizvaja z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri celica prejme gen (DNK), s katerim lahko tvori epoetin alfa.
Abseamed was studied to show that it is comparable with the reference medicine, Eprex/ Erypo, in experimental models and in humans.
Zdravilo Abseamed so raziskovali na poskusnih modelih in pri ljudeh, da bi dokazali njegovo primerljivost z referenčnim zdravilom Eprex/ Erypo.
Abseamed, 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 Abseamed 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 Abseamed or remained on Eprex/ Erypo.
Vsem bolnikom so zdravilo Eprex/ Erypo vbrizgavali v veno vsaj osem tednov, preden so bodisi začeli prejemati zdravilo Abseamed ali pa so še naprej prejemali zdravilo Eprex/ Erypo.
The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29.
Glavno merilo učinkovitosti je bila sprememba ravni hemoglobina na začetku študije in ravni v obdobju ocenjevanja, ki je potekalo med 25. in 29. tednom.
The company also presented the results of a study comparing the effects of Abseamed 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 Abseamed primerjali z zdravilom Eprex/ Erypo.
Abseamed was as effective as Eprex/ Erypo in increasing and maintaining red blood cell counts.
Zdravilo Abseamed 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 Abseamed 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 Abseamed, enako dobro vzdrževane kot pri tistih, ki so še naprej prejemali zdravilo Eprex/ Erypo.
On average, the levels of the patients taking Abseamed increased by 0.147 g/ dl from a starting value of 11.7 g/ dl.
Pri bolnikih, ki so prejemali zdravilo Abseamed, so se ravni v povprečju zvišale za 0, 147 g/ dl glede na začetno vrednost, ki je znašala 11, 7 g/ dl.
In comparison, those continuing to take Eprex/ Erypo had an increase of 0.063 g/ dl from a starting value of 12.0 g/ dl.
V primerjavi s tem je pri bolnikih, ki so še naprej prejemali zdravilo Eprex/ Erypo, povečanje znašalo 0, 063 g/ dl od začetne vrednosti 12, 0 g/ dl.
The study in patients receiving chemotherapy showed that Abseamed 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 Abseamed enako učinkovito kot podkožno vbrizgavanje zdravila Eprex/ Erypo.
The most common side effect with Abseamed 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 Abseamed so povišan krvni tlak, ki lahko včasih povzroči simptome encefalopatije (zapletov v možganih), kakršni so nenadni, migrenam podobni glavoboli z ostro bolečino in zmedenost.
Abseamed can also lead to skin rash and flu-like symptoms.
Zdravilo Abseamed lahko povzroči tudi kožne izpuščaje in gripi podobne simptome.
For the full list of all side effects reported with Abseamed, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Abseamed, glejte navodilo za uporabo.
Abseamed should not be used in people who may be hypersensitive (allergic) to epoetin alfa or any of the other ingredients.
Zdravila Abseamed 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: • 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 or stroke within the last month, who have angina pectoris (a severe type of chest pain) or who are at risk of deep 2/ 3 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.
Abseamed 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 Abseamed 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, Abseamed 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 Abseamed, ki je primerljiva z zdravilom Eprex/ Erypo.
Therefore, the CHMP’ s view was that, as for Eprex/ Erypo, the benefit outweighs the identified risks.
Zato odbor CHMP meni, da koristi tega zdravila odtehtajo ugotovljena tveganja, tako kot v primeru zdravila Eprex/ Erypo.
The Committee recommended that Abseamed be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Abseamed odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Abseamed?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Abseamed?
The company that makes Abseamed will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
Družba, ki izdeluje zdravilo Abseamed, bo za zdravstvene delavce v vseh državah članicah priskrbela informativne pakete, ki bodo vključevali tudi informacije o varnosti zdravila.
The company will also provide cool boxes for patients, which will include illustrations showing how the medicine should be used.
Družba bo za bolnike priskrbela tudi hladilne škatlice, ki bodo vključevale ilustracije, ki prikazujejo, kako se zdravilo uporablja.
Other information about Abseamed:
Druge informacije o zdravilu Abseamed:
The European Commission granted a marketing authorisation valid throughout the EU for Abseamed to Medice Arzneimittel Pütter GmbH & Co KG on 28 August 2007.
Evropska komisija je dovoljenje za promet z zdravilom Abseamed, veljavno po vsej Evropski uniji, odobrila družbi Medice Arzneimittel Pütter GmbH & Co KG dne 28. avgusta 2007.
The full EPAR for Abseamed can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Abseamed je na voljo tukaj.
This summary was last updated in 12-2008.
Povzetek je bil nazadnje posodobljen 12- 2008.
1000 IU/ 0.5 ml
1000 i. e. / 0, 5 ml
Solution for injection in a pre-filled syringe
Raztopina za injiciranje v napolnjeni injekcijski brizgi
0.5 ml (2000 IU/ ml)
0, 5 ml (2000 i. e. / ml)
1000 IU/ 0.5 ml
1000 i. e. /
Solution for injection in a pre-filled syringe
Raztopina za injiciranje
0.5 ml (2000 IU/ ml)
0, 5 ml
2000 IU/ 1.0 ml
2000 i. e. / 1, 0 ml
1.0 ml (2000 IU/ ml)
1, 0 ml (2000 i. e. / ml)
3000 IU/ 0.3 ml
3000 i. e. / 0, 3 ml
0.3 ml (10000 IU/ ml)
0, 3 ml (10000 i. e. / ml)
4000 IU/ 0.4 ml
4000 i. e. / 0, 4 ml
0.4 ml (10000 IU/ ml)
0, 4 ml (10000 i. e. / ml)
5000 IU/ 0.5 ml
5000 i. e. / 0, 5 ml
0.5 ml (10000 IU/ ml)
0, 5 ml (10000 i. e. / ml)
6000 IU/ 0.6 ml
6000 i. e. / 0, 6 ml
0.6 ml (10000 IU/ ml)
0, 6 ml (10000 i. e. / ml)
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)
7000 IU/
7000 i. e. / 0, 7 ml
9000 IU/
9000 i. e. / 0, 9 ml
0.9 ml (10000 IU/ ml)
0, 9 ml (10000 i. e. / ml)
Abseamed 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Abseamed 1. 000 i. e. / 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
Each ml of solution contains 2000 IU of epoetin alfa* corresponding to 16.8 micrograms per ml 1 pre-filled syringe of 0.5 ml contains 1000 international units (IU) corresponding to 8.4 micrograms epoetin alfa
Ena 0, 5 ml napolnjena injekcijska brizga vsebuje 1. 000 mednarodnih enot (i. e.), kar ustreza 8, 4 mikrograma epoetina alfa.
* Produced in CHO cell line by recombinant DNA technology
* Proizveden v liniji ovarijskih celic kitajskega hrčka (CHO) s tehnologijo rekombinantne DNA.
Solution for injection in a pre-filled syringe (injection)
Raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija)
Clear colourless solution
Bistra, brezbarvna raztopina
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:
Zdravljenje simptomatske anemije, povezane s kronično ledvično odpovedjo (CRF - chronic renal failure), pri odraslih in pediatričnih bolnikih:
- Treatment of anaemia associated with chronic renal failure in paediatric and adult patients on
- Zdravljenje anemije, ki je posledica kroničnega odpovedovanja ledvic, pri otrocih in odraslih
haemodialysis and adult patients on peritoneal dialysis (See section 4.4).
bolnikih, ki se zdravijo s hemodializo, in odraslih bolnikih, ki se zdravijo s peritonealno dializo (glejte poglavje 4. 4).
- Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients
- Zdravljenje hude anemije zaradi bolezni ledvic s spremljajočimi kliničnimi simptomi pri
with renal insufficiency not yet undergoing dialysis (See section 4.4).
odraslih bolnikih z ledvično insuficienco, ki še niso vključeni v zdravljenje z dializo (glejte poglavje 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).
Zdravljenje anemije in zmanjšanje potrebe po transfuziji pri odraslih bolnikih, pri katerih s kemoterapijo zdravimo solidne tumorje, maligni limfom ali multipli mielom, in pri tveganju za transfuzijo, ki ga ocenimo glede na bolnikovo splošno zdravstveno stanje (npr. kardiovaskularni status, prisotnost anemije že na začetku zdravljenja s kemoterapijo).
Abseamed can be used to increase the yield of autologous blood from patients in a predonation programme.
Zdravilo Abseamed se lahko uporablja za povečanje količine pridobljene avtologne krvi pri bolnikih v preddonorskem programu.
Its use in this indication must be balanced against the reported risk of thromboembolic events.
Njegovo uporabo pri tej indikaciji je treba pretehtati glede na tveganje za trombembolične dogodke, o katerih so poročali.
Treatment should only be given to patients with moderate anaemia (haemoglobin (Hb) 10 – 13 g/ dl [6.2 – 8.1 mmol/ l], 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).
Zdravljenje se sme uporabiti samo pri bolnikih z zmerno anemijo (hemoglobin (Hb) 10- 13 g/ dl [6, 2- 8, 1 mmol/ l], brez pomanjkanja železa), če postopki za ohranjanje krvi niso na voljo ali ne zadostujejo, kadar je za večji elektivni kirurški poseg potrebna velika količina krvi (4 ali več enot krvi za ženske ali 5 ali več enot za moške).