natgillin/translations-raw huggingface dataset:
In patients scheduled for major elective orthopaedic surgery, with a baseline haemoglobin of 10 to 13 g/ dl, the incidence of thrombotic/ vascular events (most of which were DVTs), in the overall patient population of the clinical trials, appeared to be similar across the different epoetin alfa dosing groups and placebo group, although the clinical experience is limited.
Čeprav so klinične izkušnje omejene, je bila v kliničnih raziskavah pri bolnikih, naročenih na večji elektivni ortopedski kirurški poseg in ki so imeli izhodiščno koncentracijo hemoglobina 10 do 13 g/ dl, v celotni populaciji vključenih bolnikov incidenca trombotičnih žilnih dogodkov (večinoma je šlo za globoko vensko trombozo) podobna pri vseh skupinah, ki so prejemale različne odmerke epoetina alfa, in skupini, ki je prejemala placebo.
Moreover, in patients with a baseline haemoglobin of > 13 g/ dl, the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/ vascular events cannot be excluded.
Pri bolnikih z izhodiščno koncentracijo hemoglobina > 13 g/ dl ne moremo izključiti možnosti, da je zdravljenje z epoetinom alfa lahko povezano z večjim tveganjem za pooperacijske trombotične žilne dogodke.
Overdose of epoetin alfa may produce effects that are extensions of the pharmacological effects of the hormone.
Preveliko odmerjanje epoetina alfa lahko povzroči stopnjevanje farmakoloških učinkov hormona.
Pharmacotherapeutic group: antianaemic, ATC code:
Farmakoterapevtska skupina: druga zdravila za zdravljenje slabokrvnosti, oznaka ATC:
Erythropoietin is a glycoprotein that stimulates, as a mitosis-stimulating factor and differentiating hormone, the formation of erythrocytes from precursors of the stem cell compartment.
Eritropoetin je glikoprotein, ki kot mitozo stimulirajoči dejavnik in diferenciacijski hormon spodbuja nastajanje eritrocitov iz prekurzorjev za matične celice.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
Dejanska molekulska masa eritropoetina je od 32. 000 do 40. 000 daltonov.
The protein fraction of the molecule contributes about 58% and consists of 165 amino acids.
Proteinska frakcija molekule prispeva približno 58% in sestoji iz 165 aminokislin.
The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
Štiri verige ogljikovih hidratov so prek treh N- glikozidnih vezi in ene O- glikozidne vezi vezane na protein.
Epoetin alfa obtained by gene technology is glycosylated and is identical in its amino acid and carbohydrate composition to endogenous human erythropoietin that has been isolated from the urine of anaemic patients.
Epoetin alfa, pridobljen z gensko tehnologijo, je glikoziliran in je po sestavi aminokislin in ogljikovih hidratov enak endogenemu človeškemu eritropoetinu, ki so ga izolirali iz urina bolnikov z anemijo.
Abseamed has the highest possible purity according to the present state of the art.
Zdravilo Abseamed ima največjo mogočo stopnjo čistote glede na najsodobnejše tehnološke standarde.
In particular, no residues of the cell line used for the production are detectable at the concentrations of the active ingredient that are used in humans.
Natančneje, pri koncentracijah učinkovine, ki se uporabljajo pri človeku, ni mogoče najti ostankov celične linije, ki se uporablja pri proizvodnji epoetina alfa.
The biological efficacy of epoetin alfa has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
Biološko učinkovitost epoetina alfa so dokazali na različnih živalskih modelih in vivo (zdrave podgane in podgane z anemijo, miši s policitemijo).
After administration of epoetin alfa, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
Po uporabi epoetina alfa se zveča število eritrocitov, vrednosti Hb in število retikulocitov ter hitrost vgrajevanja 59Fe.
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin alfa.
12 In vitro (celične kulture vranice miši) so ugotovili povečano vgrajevanje 3H- timidina v eritroidne jedrne celice vranice po inkubaciji z epoetinom alfa.
It could be shown with the aid of cell cultures of human bone marrow cells that epoetin alfa stimulates erythropoiesis specifically and does not affect leucopoiesis.
S pomočjo celičnih kultur kostnega mozga človeka so pokazali, da epoetin alfa spodbuja zgolj eritropoezo in ne vpliva na levkopoezo.
Cytotoxic actions of epoetin alfa on bone marrow cells could not be detected.
Citotoksičnih učinkov epoetina alfa na celice kostnega mozga niso ugotovili.
12 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
Od 721 bolnikov z rakom, zdravljenih s kemoterapijo, ki niso prejemali učinkovin, ki vsebujejo platino, in ki so bili vključeni v tri študije, nadzorovane s placebom, je imelo 389 bolnikov hematološka maligna obolenja (221 multipli mielom, 144 Nehodgkinov limfom in 24 druge hematološke malignosti) in 332 solidne tumorje (172 tumor dojke, 64 tumor na rodilih, 23 tumor pljuč, 22 tumor prostate, 21 tumor prebavil in 30 tumor drugih vrst).
In two large, open-label studies, 2697 cancer patients receiving non-platinum chemotherapy were included, 1895 with solid tumours (683 breast, 260 lung, 174 gynaecological, 300 gastro-intestinal, and 478 other tumour types) and 802 with haematological malignancies.
Od 2. 697 bolnikov z rakom, zdravljenih s kemoterapijo, ki niso prejemali učinkovin, ki vsebujejo platino, in ki so bili vključeni v dve obsežni odprti študiji, je imelo 1. 895 bolnikov solidne tumorje (683 tumor dojke, 260 tumor pljuč, 174 tumor na rodilih, 300 tumor prebavil in 478 tumor drugih vrst), 802 pa hematološka maligna obolenja.
Functional Assessment of Cancer Therapy- Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
V prospektivni, randomizirani, dvojno slepi študiji, nadzorovani s placebom, v kateri je sodelovalo 375 bolnikov z anemijo z različnimi nemieloidnimi malignimi obolenji, ki so se zdravili s kemoterapijo brez platine, so z meritvami, ki so jih izvedli s pomočjo naslednjih inštrumentov in lestvic: splošna lestvica za funkcionalno oceno zdravljenja anemičnih bolnikov z rakom (FACT- An – Functional Assessment of Cancer Therapy- Anaemia), lestvica utrujenosti FACT- An in linearna analogna lestvica pri bolnikih z rakom (CLAS – Cancer Linear Analogue Scale), opazili pomembno zmanjšanje posledic, povezanih z anemijo (npr. utrujenost, zmanjšana energija in telesna aktivnost).
Two other smaller, randomised, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Na lestvici EORTC- QLQ- C30 oziroma CLAS drugi, manjši, randomizirani, s placebom nadzorovani študiji nista pokazali pomembnega izboljšanja parametrov kakovosti življenja.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Preživetje in napredovanje tumorja so raziskovali v petih velikih nadzorovanih študijah, v katerih je sodelovalo skupno 2. 833 bolnikov, med katerimi so bile štiri študije dvojno slepe in nadzorovane s placebom, ena pa je bila odprta.
The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which erythropoiesis stimulating agents are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
V študiji so bili vključeni bodisi bolniki, ki so prejemali kemoterapijo (dve študiji), ali bolniki, pri katerih uporaba zdravil, ki spodbujajo eritropoiezo, ni bila indicirana: anemija pri bolnikih z rakom, ki niso prejemali kemoterapije, in bolniki z rakom glave in vratu, ki so prejemali radioterapijo.
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12 - 14 g/ dl.
V dveh študijah je bila ciljna koncentracija hemoglobina > 13 g/ dl, v preostalih dveh pa 12– 14 g/ dl.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
V štirih, s placebom kontroliranih študijah je bilo razmerje ogroženosti za celokupno preživetje med 1, 25 in 2, 47 v korist kontrolne skupine.
These studies have shown an consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Te študije so pokazale skladno, nerazložljivo, statistično značilno povečano umrljivost bolnikov, pri katerih je bila anemija povezana z različnimi, pogostimi vrstami raka in ki so prejemali rekombinantni humani eritropoetin, v primerjavi s kontrolno skupino.
Overall survival outcome in the trials could not be statisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Izida za celokupno preživetje v preskušanjih se med tistimi, ki so prejemali rekombinantni humani eritropoetin, in tistimi v kontrolni skupini, ni dalo zadovoljivo razložiti s pomočjo razlik v incidenci tromboze in sorodnih zapletov.
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Opravili so tudi sistematični pregled podatkov, v katerega je bilo vključeno več kot 9. 000 bolnikov z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
Pri metaanalizi podatkov o skupnem preživetju so dobili oceno razmerja tveganja 1, 08 v prid kontrolnim skupinam (95- odstotni IZ:
0.99, 1,18; 42 trials and 8167 patients).
0, 99, 1, 18; 42 preskušanj in 8. 167 bolnikov).
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
Pri bolnikih, ki so prejemali rekombinantni humani eritropoetin, so opazili povečano relativno tveganje za trombembolične dogodke (RT 1, 67, 95- odstotni IZ:
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
1, 35, 2, 06, 35 preskušanj in 6. 769 bolnikov).
There is an increased risk for thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Obstaja povišano tveganje tromboembolitičnih dogodkov pri bolnikih z rakom, zdravljenih z rekombinantnim humanim eritropoietinom, zato negativnega vpliva na splošno stopnjo preživetja ni možno izključiti.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
V kakšni meri ti rezultati veljajo za dajanje rekombinantnega humanega eritropoetina bolnikom z rakom na kemoterapiji za doseganje koncentracije hemoglobina pod 13 g/ dl ni jasno, saj so v ta pregled podatkov vključili malo takšnih bolnikov.
5.2 Pharmacokinetic properties
13 5. 2 Farmakokinetične lastnosti
Intravenous route
Intravenska uporaba
Measurement of epoetin alfa following multiple dose intravenous administration revealed a half-life of approximately 4 hours in normal volunteers and a somewhat more prolonged half-life in renal failure patients, approximately 5 hours.
Z določanjem koncentracije epoetina alfa po intravenskem injiciranju več odmerkov je bilo ugotovljeno, da je razpolovna doba pri zdravih prostovoljcih približno 4 ure, pri bolnikih z ledvično odpovedjo pa nekoliko podaljšana, na približno 5 ur.
A half-life of approximately 6 hours has been reported in children.
Pri otrocih so poročali o razpolovni dobi približno 6 ur.
Subcutaneous route
Subkutana uporaba
Following subcutaneous injection, serum levels of epoetin alfa are much lower than the levels achieved following intravenous injection, the levels increase slowly and reach a peak between 12 and
Serumske koncentracije epoetina alfa po subkutanem injiciranju so veliko manjše od koncentracij po intravenskem injiciranju.
13 18 hours postdose.
Serumska koncentracija zdravila narašča počasi in vrh doseže med 12 in 18 urami po danem odmerku.
The peak is always well below the peak achieved using the intravenous route (approximately 1/ 20th of the value).
Največja serumska koncentracija je vedno precej manjša od tiste, ki je dosežena z intravensko uporabo zdravila (približno 1/ 20 vrednosti).
There is no accumulation: the levels remain the same, whether they are determined 24 hours after the first injection or 24 hours after the last injection.
Zdravilo se v telesu ne kopiči: njegova koncentracija ostane enaka, če je določena 24 ur po prvi injekciji ali 24 ur po zadnji injekciji.
The half-life is difficult to evaluate for the subcutaneous route and is estimated about 24 hours.
Razpolovno dobo je pri subkutani uporabi težko določiti, ocenjena pa je na približno 24 ur.
The bioavailability of subcutaneous injectable epoetin alfa is much lower than that of the intravenous medicinal product: approximately 20%.
Biološka uporabnost subkutano injiciranega epoetina alfa je veliko manjša od biološke uporabnosti intravensko injiciranega zdravila: za približno 20%.
In some preclinical toxicological studies in dogs and rats, but not in monkeys, epoetin alfa therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
Nekatere predklinične toksikološke študije na psih in podganah, toda ne na opicah, so pokazale, da je zdravljenje z epoetinom alfa povezano s subklinično fibrozo kostnega mozga (Fibroza kostnega mozga je znan zaplet pri ljudeh s kroničnim ledvičnim odpovedovanjem in je lahko povezana s sekundarnim hiperparatiroidizmom ali neznanimi dejavniki.
The incidence of bone marrow fibrosis was not increased in a study of haemodialysis patients who were treated with epoetin alfa for 3 years compared to a matched control group of dialysis patients who had not been treated with epoetin alfa.).
Študija pri bolnikih na hemodializi, ki so se 3 leta zdravili z epoetinom alfa, ni pokazala večje incidence fibroze kostnega mozga v primerjavi z enako kontrolno skupino bolnikov na dializi, ki se niso zdravili z epoetinom alfa).
In animal studies, epoetin alfa has been shown to decrease foetal body weight, delay ossification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose.
Študije na živalih so pokazale, da epoetin alfa zmanjšuje telesno maso ploda, upočasni osifikacijo in poveča umrljivost ploda, če se zdravilo daje v tedenskih odmerkih, ki so približno 20- krat večji od tedenskih odmerkov, priporočljivih za ljudi.
These changes are interpreted as being secondary to decreased maternal body weight gain.
Spremembe si lahko razložimo kot sekundarno posledico materinega počasnega pridobivanja telesne mase.
Epoetin alfa did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.
Pri testih mutagenosti na celičnih kulturah bakterij in sesalcev in pri mikronukleusnem testu in vivo pri miših uporaba epoetina alfa ni povzročila nobenih sprememb.
There are conflicting reports in the literature regarding whether erythropoietins may play a major role as tumour proliferators.
V literaturi najdemo nasprotujoča si poročila o vlogi eritropoetinov pri pospeševanju proliferacije tumorjev.
These reports are based on in vitro findings from human tumour samples, but are of uncertain significance in the clinical situation.
Ta poročila temeljijo na izsledkih, dobljenih in vitro na vzorcih človeških tumorjev, vendar njihov pomen za klinično prakso ni znan.
Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Glycine Polysorbate 80 Water for injections Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
natrijev dihidrogenfosfat dihidrat dinatrijev fosfat dihidrat natrijev klorid glicin polisorbat 80 voda za injekcije klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
6.2 Incompatibilities
14 6. 2 Inkompatibilnosti
Keep the pre-filled syringe in the outer carton in order to protect from light.
Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini, za zagotovitev zaščite pred svetlobo.
14 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Pri ambulantnem zdravljenju lahko bolnik zdravilo Abseamed hrani izven hladilnika, pri temperaturi pod 25 °C, največ 3 dni.
Pre-filled syringes (glass type I) with plunger (Teflon-faced rubber) sealed in a blister.
Napolnjene injekcijske brizge (steklo tipa I) z batom (s teflonom prevlečena guma) v pretisnem omotu.
The syringes contain 0.5 ml (1000 IU) of solution.
Brizge vsebujejo 0, 5 ml (1. 000 i. e.) raztopine.
Syringes are embossed with graduation rings and the filling volume is indicated by a stick-on label in order to enable partial use if required.
Brizge imajo relief prstana, polnilni volumen pa je označen z nalepko, ki omogoča delno uporabo, če je to potrebno.
Abseamed must not be used
Zdravila Abseamed se ne sme uporabiti:
- if the solution is cloudy or there are particles in it.
- če je raztopina motna in so v njej vidni delci,
- if the seal is broken.
- če je tesnilo poškodovano,
- if the solution has been accidentally frozen.
- če je bila raztopina pomotoma zamrznjena.
The pre-filled syringes are ready to use (see section 4.2 – Method of administration).
Napolnjene injekcijske brizge so pripravljene za uporabo (glejte poglavje 4. 2 – Način uporabe).
After injection of the necessary amount of the solution from the pre-filled syringe, discard any remaining contents.
Po injiciranju potrebne količine raztopine iz napolnjene injekcijske brizge zavrzite vso preostalo vsebino.
Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn
Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D- 58638 Iserlohn Nemčija
28 August 2007
28. avgust 2007
Abseamed 2000 IU/ 1 ml solution for injection in a pre-filled syringe
Abseamed 2. 000 i. e. / 1 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 1 ml contains 2000 international units (IU) corresponding to 16.8 micrograms epoetin alfa
Ena 1 ml napolnjena injekcijska brizga vsebuje 2. 000 mednarodnih enot (i. e.), kar ustreza 16, 8 mikrograma epoetina alfa.
4.2 Posology and method of administration
17 4. 2 Odmerjanje in način uporabe
16 Posology
Odmerjanje
Paediatric haemodialysis patients:
18 Otroci, ki se zdravijo s hemodializo:
17 Correction phase:
Korekcijska faza:
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).
Variabilnost hemoglobina je treba obravnavati s prilagajanjem odmerka, pri tem pa je treba upoštevati ciljno 19 območje hemoglobina od 10 g/ dl (6, 2 mmol/ l) do 12 g/ dl (7, 5 mmol/ l).
18 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 ustrezno prilagajanje odmerka, kadar vrednosti hemoglobina presežejo 12 g/ dl (7, 5 mmol/ l), so opisane spodaj.
19 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
20 150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg enkrat na teden
Treatment of adult patients scheduled for major elective orthopaedic surgery:
21 Zdravljenje odraslih bolnikov, naročenih na večji elektivni ortopedski kirurški poseg:
20 The recommended dose is 600 IU/ kg epoetin alfa, given weekly for three weeks (days 21, 14 and 7) prior to surgery and on the day of surgery (day 0).
Priporočeni odmerek je 600 i. e. / kg epoetina alfa, ki se daje na teden v obdobju treh tednov (na 21., 14. in 7. dan) pred kirurškim posegom in na dan kirurškega posega (dan 0).
4.4 Special warnings and precautions for use
22 4. 4 Posebna opozorila in previdnostni ukrepi
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
23 hemoglobina, dosežena z zdravili za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent), nad 12 g/ dl (7, 5 mmol/ l).
22 (0.62 mmol/ l) per month and should not exceed 2 g/ dl (1.25 mmol/ l) per month to minimise risks of an increase in hypertension.
Da bi zmanjšali tveganje za poslabšanje hipertenzije, je treba koncentracijo hemoglobina povečevati za približno 1 g/ dl (0, 62 mmol/ l) na mesec in ne hitreje kot za 2 g/ dl (1, 25 mmol/ l) na mesec.
Adult surgery patients in an autologous predonation programme
24 Odrasli bolniki, naročeni na kirurški poseg, ki sodelujejo v avtolognem preddonorskem programu:
23 Patients scheduled for major elective orthopaedic surgery
Odrasli bolniki, naročeni na večji elektivni ortopedski kirurški poseg
4.6 Pregnancy and lactation
25 4. 6 Nosečnost in dojenje
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
26 Pri teh bolnikih je priporočena zgodnja revizija šanta in antiagregacijska profilaksa z uporabo acetilsalicilne kisline.
25 An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
Pri bolnikih, ki so prejemali eritropoetična zdravila, so opazili zvečano incidenco trombotičnih žilnih dogodkov (glejte poglavji 4. 4 in 4. 8 – Splošni).
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin alfa.
27 In vitro (celične kulture vranice miši) so ugotovili povečano vgrajevanje 3H- timidina v eritroidne jedrne celice vranice po inkubaciji z epoetinom alfa.
26 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
Od 721 bolnikov z rakom, zdravljenih s kemoterapijo, ki niso prejemali učinkovin, ki vsebujejo platino, in ki so bili vključeni v tri študije, nadzorovane s placebom, je imelo 389 bolnikov hematološka maligna obolenja (221 multipli mielom, 144 Nehodgkinov limfom in 24 druge hematološke malignosti) in 332 solidne tumorje (172 tumor dojke, 64 tumor na rodilih, 23 tumor pljuč, 22 tumor prostate, 21 tumor prebavil in 30 tumor drugih vrst).
5.2 Pharmacokinetic properties
28 5. 2 Farmakokinetične lastnosti
27 18 hours postdose.
Serumska koncentracija zdravila narašča počasi in vrh doseže med 12 in 18 urami po danem odmerku.
6.2 Incompatibilities
29 6. 2 Inkompatibilnosti
28 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Pri ambulantnem zdravljenju lahko bolnik zdravilo Abseamed hrani izven hladilnika, pri temperaturi pod 25 °C, največ 3 dni.
The syringes contain 1 ml (2000 IU) of solution.
Brizge vsebujejo 1 ml (2. 000 i. e.) raztopine.