natgillin/translations-raw huggingface dataset:
144 ANNEX III
154 DODATEK III
146 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
156 PODATKI NA ZUNANJI OVOJNINI
1 pre-filled syringe of 0.5 ml contains 1000 international units (IU) corresponding to 8.4 micrograms epoetin alfa
0, 5 ml napolnjena injekcijska brizga vsebuje 1. 000 mednarodnih enot (i. e.) epoetina alfa, kar ustreza 8, 4 mikrograma epoetina alfa.
Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections
Pomožne snovi: natrijev dihidrogenfosfat dihidrat, dinatrijev fosfat dihidrat, natrijev klorid, glicin, polisorbat 80, klorovodikova kislina (za prilagajanje pH), natrijev hidroksid (za prilagajanje pH) in voda za injekcije.
1 pre-filled syringe of 0.5 ml 6 pre-filled syringes of 0.5 ml
1 napolnjena injekcijska brizga z 0, 5 ml 6 napolnjenih injekcijskih brizg z 0, 5 ml
EXP
Uporabno do
Store and transport refrigerated (2°C - 8°C).
Zdravilo shranjujte in prevažajte na hladnem (2 °C– 8 °C).
Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany
Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D- 58638 Iserlohn, Nemčija
Abseamed 1000 IU/ 0.5 ml
Abseamed 1. 000 i. e. / 0, 5 ml
148 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
158 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
149 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
159 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
LABEL/ SYRINGE
NALEPKA/ BRIZGA
Abseamed 1000 IU/ 0.5 ml injection
Abseamed 1. 000 i. e. / 0, 5 ml injekcija
Epoetin alfa IV/ SC
epoetin alfa i. v. / s. c.
150 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
160 PODATKI NA ZUNANJI OVOJNINI
1 pre-filled syringe of 1 ml contains 2000 international units (IU) corresponding to 16.8 micrograms epoetin alfa
1 ml napolnjena injekcijska brizga vsebuje 2. 000 mednarodnih enot (i. e.) epoetina alfa, kar ustreza 16, 8 mikrograma epoetina alfa.
1 pre-filled syringe of 1 ml 6 pre-filled syringes of 1 ml
1 napolnjena injekcijska brizga z 1 ml 6 napolnjenih injekcijskih brizg z 1 ml
Abseamed 2000 IU/ 1 ml
Abseamed 2. 000 i. e. / 1 ml
152 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
162 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
153 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
163 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Abseamed 2000 IU/ 1 ml injection
Abseamed 2. 000 i. e. / 1 ml injekcija
154 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
164 PODATKI NA ZUNANJI OVOJNINI
1 pre-filled syringe of 0.3 ml contains 3000 international units (IU) corresponding to 25.2 micrograms epoetin alfa
0. 3 ml napolnjena injekcijska brizga vsebuje 3. 000 mednarodnih enot (i. e.) epoetina alfa, kar ustreza 25, 2 mikrograma epoetina alfa.
1 pre-filled syringe of 0.3 ml 6 pre-filled syringes of 0.3 ml
1 napolnjena injekcijska brizga z 0, 3 ml 6 napolnjenih injekcijskih brizg z 0, 3 ml
Abseamed 3000 IU/ 0.3 ml
Abseamed 3. 000 i. e. / 0, 3 ml
156 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
166 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
157 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
167 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Abseamed 3000 IU/ 0.3 ml injection
Abseamed 3. 000 i. e. / 0, 3 ml injekcija
158 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
168 PODATKI NA ZUNANJI OVOJNINI
1 pre-filled syringe of 0.4 ml contains 4000 international units (IU) corresponding to 33.6 micrograms epoetin alfa
0. 4 ml napolnjena injekcijska brizga vsebuje 4. 000 mednarodnih enot (i. e.) epoetina alfa, kar ustreza 33, 6 mikrograma epoetina alfa.
1 pre-filled syringe of 0.4 ml 6 pre-filled syringes of 0.4 ml
1 napolnjena injekcijska brizga z 0, 4 ml 6 napolnjenih injekcijskih brizg z 0, 4 ml
Abseamed 4000 IU/ 0.4 ml
Abseamed 4. 000 i. e. / 0, 4 ml
160 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
170 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
161 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
171 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Abseamed 4000 IU/ 0.4 ml injection
Abseamed 4. 000 i. e. / 0, 4 ml injekcija
162 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
172 PODATKI NA ZUNANJI OVOJNINI
1 pre-filled syringe of 0.5 ml contains 5000 international units (IU) corresponding to 42.0 micrograms epoetin alfa
0. 5 ml napolnjena injekcijska brizga vsebuje 5. 000 mednarodnih enot (i. e.) epoetina alfa, kar ustreza 42, 0 mikrograma epoetina alfa.
Abseamed 5000 IU/ 0.5 ml
Abseamed 5. 000 i. e. / 0, 5 ml
164 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
174 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
165 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
175 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Abseamed 5000 IU/ 0.5 ml injection
Abseamed 5. 000 i. e. / 0, 5 ml injekcija
166 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
176 PODATKI NA ZUNANJI OVOJNINI
1 pre-filled syringe of 0.6 ml contains 6000 international units (IU) corresponding to 50.4 micrograms epoetin alfa
0. 6 ml napolnjena injekcijska brizga vsebuje 6. 000 mednarodnih enot (i. e.) epoetina alfa, kar ustreza 50, 4 mikrograma epoetina alfa.
1 pre-filled syringe of 0.6 ml 6 pre-filled syringes of 0.6 ml
1 napolnjena injekcijska brizga z 0, 6 ml 6 napolnjenih injekcijskih brizg z 0, 6 ml
Abseamed 6000 IU/ 0.6 ml
Abseamed 6. 000 i. e. / 0, 6 ml
168 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
178 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
169 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
179 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Abseamed 6000 IU/ 0.6 ml injection
Abseamed 6. 000 i. e. / 0, 6 ml injekcija
170 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
180 PODATKI NA ZUNANJI OVOJNINI
1 pre-filled syringe of 0.7 ml contains 7000 international units (IU) corresponding to 58.8 micrograms epoetin alfa
0, 7 ml napolnjena injekcijska brizga vsebuje 7. 000 mednarodnih enot (i. e.) epoetina alfa, kar ustreza 58, 8 mikrograma epoetina alfa.
1 pre-filled syringe of 0.7 ml 6 pre-filled syringes of 0.7 ml
1 napolnjena injekcijska brizga z 0, 7 ml 6 napolnjenih injekcijskih brizg z 0, 7 ml
Abseamed 7000 IU/ 0.7 ml
Abseamed 7. 000 i. e. / 0, 7 ml
172 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
182 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
173 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
183 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Abseamed 7000 IU/ 0.7 ml injection
Abseamed 7. 000 i. e. / 0, 7 ml injekcija
174 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
184 PODATKI NA ZUNANJI OVOJNINI
1 pre-filled syringe of 0.8 ml contains 8000 international units (IU) corresponding to 67.2 micrograms epoetin alfa
0. 8 ml napolnjena injekcijska brizga vsebuje 8. 000 mednarodnih enot (i. e.) epoetina alfa, kar ustreza 67, 2 mikrograma epoetina alfa.
1 pre-filled syringe of 0.8 ml 6 pre-filled syringes of 0.8 ml
1 napolnjena injekcijska brizga z 0, 8 ml 6 napolnjenih injekcijskih brizg z 0, 8 ml
Abseamed 8000 IU/ 0.8 ml
Abseamed 8. 000 i. e. / 0, 8 ml
176 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
186 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
177 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
187 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Abseamed 8000 IU/ 0.8 ml injection
Abseamed 8. 000 i. e. / 0, 8 ml injekcija
178 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
188 PODATKI NA ZUNANJI OVOJNINI
1 pre-filled syringe of 0.9 ml contains 9000 international units (IU) corresponding to 75.6 micrograms epoetin alfa
0, 9 ml napolnjena injekcijska brizga vsebuje 9. 000 mednarodnih enot (i. e.) epoetina alfa, kar ustreza 75, 6 mikrograma epoetina alfa.
1 pre-filled syringe of 0.9 ml 6 pre-filled syringes of 0.9 ml
1 napolnjena injekcijska brizga z 0, 9 ml 6 napolnjenih injekcijskih brizg z 0, 9 ml
Abseamed 9000 IU/ 0.9 ml
Abseamed 9. 000 i. e. / 0, 9 ml
180 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
190 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
181 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
191 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Abseamed 9000 IU/ 0.9 ml injection
Abseamed 9. 000 i. e. / 0, 9 ml injekcija
182 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
192 PODATKI NA ZUNANJI OVOJNINI
1 pre-filled syringe of 1 ml contains 10 000 international units (IU) corresponding to 84.0 micrograms epoetin alfa
1 ml napolnjena injekcijska brizga vsebuje 10. 000 mednarodnih enot (i. e.) epoetina alfa, kar ustreza 84, 0 mikrograma epoetina alfa.
Abseamed 10 000 IU/ 1 ml
Abseamed 10. 000 i. e. / 1 ml
184 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
194 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
185 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
195 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Abseamed 10 000 IU/ 1 ml injection
Abseamed 10. 000 i. e. / 1 ml injekcija
INFORMATION FOR THE USER
197 NAVODILO ZA UPORABO
Abseamed 10 000 IU/ 1 ml solution for injection in a pre-filled syringe Epoetin alfa
Abseamed 10. 000 i. e. / 1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin alfa
It may harm them, even
Njim bi lahko celo
if their symptoms are the same as yours.
škodovalo, čeprav imajo znake bolezni, podobne vašim.
please tell your doctor or pharmacist.
omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Abseamed is and what it is used for 2.
Kaj je zdravilo Abseamed in za kaj ga uporabljamo 2.
Before you use Abseamed 3.
Kaj morate vedeti, preden boste uporabili zdravilo Abseamed 3.
How to use Abseamed 4.
Kako uporabljati zdravilo Abseamed 4.
How to store Abseamed 6.
Shranjevanje zdravila Abseamed 6.
WHAT ABSEAMED IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ABSEAMED IN ZA KAJ GA UPORABLJAMO
Abseamed contains a hormone called epoetin alfa, which stimulates the production of red blood cells.
Zdravilo Abseamed vsebuje hormon, imenovan epoetin alfa, ki spodbuja tvorbo rdečih krvnih celic.
Epoetin alfa is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin.
Njegovo delovanje je popolnoma enako delovanju naravnega hormona eritropoetina.
Abseamed is used: for treating symptomatic anaemia associated with kidney disease (given by injection into a vein) in children and adults on dialysis in adults on peritoneal dialysis for treating severe symptomatic anaemia caused by kidney disease in adults not yet undergoing dialysis (given by injection into a vein) for treating anaemia and reducing the need for a blood transfusion in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the doctor in moderately anaemic patients who are going to have surgery and prior to it, donate blood so that their own blood can be given to them during or after surgery (autologous predonation) as an alternative to a blood transfusion in adult patients about to undergo major orthopaedic (bone) surgery where there is a potentially high risk from blood transfusion complications
Zdravilo Abseamed se uporablja za: zdravljenje simptomatske anemije, ki je posledica ledvične bolezni (daje se z injiciranjem v veno) pri otrocih in odraslih bolnikih, ki se zdravijo z dializo pri odraslih bolnikih, ki se zdravijo s peritonealno dializo zdravljenje hude simptomatske anemije, ki je posledica ledvične bolezni, pri odraslih bolnikih, ki se še ne zdravijo z dializo (daje se z injiciranjem v veno) zdravljenje anemije in zmanjšanje potrebe po transfuziji krvi pri odraslih bolnikih, pri katerih s kemoterapijo zdravijo solidne tumorje, maligni limfom ali multipli mielom, in imajo po oceni zdravnika večje tveganje za transfuzijo krvi zdravljenje zmerno anemičnih bolnikov, naročenih na kirurški poseg, ki pred posegom darujejo kri, da lahko med kirurškim posegom ali po njem prejmejo lastno kri (avtologna preddonacija)
BEFORE YOU USE ABSEAMED
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO ABSEAMED
Do not use Abseamed:
Ne uporabljajte zdravila Abseamed:
- if you are allergic (hypersensitive) to epoetin alfa or any of the other ingredients of Abseamed
- če ste alergični (preobčutljivi) na epoetin alfa ali katerokoli sestavino zdravila Abseamed
- if you have developed Pure Red Cell Aplasia (reduced or stopped production of red blood cells)
- če se je po zdravljenju s katerim koli eritropoetinom pri vas razvila aplazija rdečih krvnih celic
following treatment with any erythropoietin
(zmanjšano ali ustavljeno nastajanje rdečih krvnih celic)
- if you have high blood pressure which is not properly controlled
- če imate zvišan krvni tlak, ki ni ustrezno nadzorovan
- if you are donating your own blood before surgery, and:
- če boste za kirurški poseg darovali lastno kri in:
• you had a heart attack or stroke in the month before your treatment • you have unstable angina pectoris (new or increasing chest pain) • you are at risk of blood clots in the veins (deep venous thrombosis) – for example, if you have had clots before
• ste v mesecu pred zdravljenjem imeli srčno ali možgansko kap, • imate nestabilno angino pektoris (novo bolečino v prsnem košu ali njeno krepitev), • če pri vas obstaja nevarnost nastanka krvnih strdkov v venah (globoka venska tromboza) – na primer če ste v preteklosti imeli strdke.
- if you cannot receive adequate treatment for the prevention of blood clots (antithrombotic
- če ne smete jemati zdravil za preprečevanje nastanka krvnih strdkov (antiagregacijska
prophylaxis)
profilaksa)
- if you are due to have major orthopaedic surgery and:
- če ste naročeni na večji ortopedski kirurški poseg in:
you have severe disorders of blood circulation of the heart (coronary heart disease), arteries of the legs or arms (peripheral arterial occlusive disease), neck vessels (vascular disease of the carotids) or the brain (cerebrovascular disease) you had a recent heart attack or stroke
imate hude motnje krvnega obtoka v srcu (koronarna srčna bolezen), arterijah v nogah in rokah (periferna arterijska okluzivna bolezen), vratnih žilah (bolezen karotidnih žil) ali možganih (cerebrovaskularna bolezen) ste pred kratkim preboleli srčno ali možgansko kap
If any of these applies to you, or might apply, tell your doctor at once.
Če karkoli od naštetega velja oziroma bi lahko veljalo za vas, se o tem takoj posvetujte s svojim zdravnikom.
Take special care with Abseamed:
Bodite posebno pozorni pri uporabi zdravila Abseamed:
In all patients treated with Abseamed blood pressure should be closely monitored and treated, if necessary.
Pri vseh bolnikih, ki so zdravljeni z zdravilom Abseamed, je treba skrbno spremljati krvni tlak in ga po potrebi zdraviti.
Abseamed should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
Pri bolnikih z nezdravljeno, neustrezno zdravljeno ali slabo nadzorovano hipertenzijo je treba zdravilo Abseamed uporabljati previdno.
It may be necessary to initiate or increase treatment against high blood pressure.
Morda bo treba uvesti ali zvečati odmerek zdravila za zdravljenje visokega krvnega tlaka.
If blood pressure cannot be controlled, Abseamed treatment should be discontinued.
Če krvnega tlaka ni mogoče nadzorovati, je treba zdravljenje z zdravilom Abseamed prekiniti.
Take special care with Abseamed if you have epilepsy or chronic liver disease.
Zdravilo Abseamed je treba uporabljati še posebej previdno, če imate epilepsijo ali kronično bolezen jeter.
There may be a moderate dose-dependent increase in the platelet count within the normal range during treatment with Abseamed, which gradually regresses during the course of continued therapy.
Med zdravljenjem z zdravilom Abseamed se lahko število trombocitov, odvisno od velikosti odmerka, zmerno zveča, vendar ostane v normalnih mejah in se ob nadaljevanju zdravljenja ponovno postopoma zmanjša.
Your doctor may do regular blood tests to check your blood platelet count during the first 8 weeks of therapy.
Zdravnik lahko v prvih osmih tednih zdravljenja odredi redno opravljanje krvnih preiskav, s katerimi bo preverjal število trombocitov.
All other causes of anaemia, e. g. iron deficiency, damage of red blood cells (haemolysis), blood loss, vitamin B12 or folate deficiency, should be taken into account and treated prior to initiating therapy with Abseamed.
Pred začetkom zdravljenja z zdravilom Abseamed je treba upoštevati in zdraviti vse druge vzroke anemije, npr. pomanjkanje železa, poškodbe rdečih krvnih celic (hemoliza), izgubo krvi, pomanjkanje vitamina B12 ali folata.
In order to ensure optimum response to Abseamed adequate iron stores should be ensured.
Za optimalen odziv na zdravljenje z zdravilom Abseamed, je treba zagotoviti ustrezne zaloge železa.
Your doctor may do blood tests to decide, if you need iron supplements.
Zdravnik bo morda opravil krvne preiskave, da bi ugotovil, če potrebujete nadomestke železa.
Pure Red Cell Aplasia (PRCA)
Aplazija rdečih krvnih celic (PRCA)
Antibody-mediated PRCA has been very rarely reported in patients after months to years of subcutaneous (injection under the skin) erythropoietin treatment.
Po več mesecih ali letih zdravljenja s subkutanim (injiciranje pod kožo) eritropoetinom so zelo redko poročali o pojavu aplazije PRCA, povzročene s protitelesi.
PRCA means the inability to produce enough red blood cells in the bone marrow.
Povzroči lahko nenadno
PRCA can result in sudden and severe anaemia, the symptoms of which are unusual tiredness, feeling dizzy or breathlessness.
199 in hudo anemijo, ki se kaže s simptomi neobičajne utrujenosi, omotice in zasoplosti.
If you experience these symptoms you should talk to your doctor at once.
Ob pojavu teh simptomov se takoj posvetujte s svojim zdravnikom.
Your doctor can decide whether Abseamed is not working properly for you.
Presodil bo, ali zdravilo Abseamed pri vas ne deluje ustrezno.
If you develop PRCA your Abseamed therapy will be discontinued and your doctor will decide how best to treat your anaemia.
Če se pri vas pojavi aplazija rdečih krvnih celic, bo zdravljenje z zdravilom Abseamed prekinjeno, zdravnik pa bo odločil, kako najbolje zdraviti anemijo.
189 Kidney patients
Bolniki z ledvično boleznijo
There is not much experience with subcutaneous use (injection into the skin) of Abseamed in kidney patients.
S subkutano uporabo (injiciranje pod kožo) zdravila Abseamed pri ledvičnih bolnikih ni veliko izkušanj.
Therefore, if you are being treated for anaemia associated with kidney disease, Abseamed has to be given by injection into a vein (intravenously).
Če se zdravite zaradi anemije, povezane z boleznijo ledvic, je treba zdravilo Abseamed injicirati v veno (intravensko).
Your doctor will check your levels of the red blood pigment (haemoglobin) regularly
Zdravnik bo redno preverjal vrednosti rdečega pigmenta v vaši krvi (hemoglobina) da zagotovi, da hemoglobin ne preseže neke ravni, saj bi lahko visoka raven hemoglobina
you at risk of having a problem of the heart or the blood vessels and could increase risk of death
povzročila težave s srcem ali krvnimi žilami ter povečala tveganje smrti da bi čim bolj zmanjšal tveganje za zvišanje krvnega tlaka.
Increased levels of potassium (hyperkalaemia) have been observed in isolated cases.
V posameznih primerih so opazili zvečane vrednosti kalija (hiperkaliemija).
The correction of your anaemia may lead to increased appetite, and thus increased potassium and protein intake.
Izboljšanje anemije lahko vodi do povečanja teka in posledično do večjega vnosa kalija in beljakovin.
Therefore dialysis procedures may have to be adjusted to maintain urea, creatinine and potassium in the desired range.
Zato bo morda potrebno občasno prilagoditi režim dialize, da bi koncentracijo sečnine, kreatinina in kalija ohranjali v okviru želenih meja.
Serum electrolytes should be monitored.
Spremljati je treba tudi serumske koncentracije elektrolitov.
If an elevated or increasing serum potassium level is detected, your doctor may consider to discontinue the treatment with Abseamed until the potassium level has returned to the normal range.
Če je ugotovljeno povečanje serumske koncentracije kalija, bo zdravnik zdravljenje z zdravilom Abseamed morda prekinil, dokler se vrednosti kalija ne vrnejo v normalne meje.
An increase in dose of a particular blood-thinning medicine (heparin) during haemodialysis is frequently required during the course of therapy with Abseamed.
Med zdravljenjem z zdravilom Abseamed je treba zaradi zvečanega hematokrita med dializo pogosto zvečati odmerek posebnega zdravila za redčenje krvi (heparina).
Inadequate thinning of the blood by heparin (heparinisation) may lead to occlusion of the dialysis system.
Če redčenje krvi s heparinom (heparinizacija) ni ustrezno, lahko pride do zapore dializnega sistema.
If you have chronic kidney failure and clinically evident coronary heart disease or signs of congestion due to inadequate heart output, your doctor will make sure that your haemoglobin levels do not exceed a certain level.
Če imate kronično ledvično odpovedovanje in klinično izraženo koronarno bolezen srca ali znake kongestivnega srčnega popuščanja, ki je posledica pomanjkljive oskrbe s krvjo, bo zdravnik poskrbel, da koncentracije hemoglobina ne bodo presegle določene meje.
Based on information available to date, treatment of anaemia with Abseamed in adult patients with chronic kidney failure (renal insufficiency) who do not yet require dialysis, does not accelerate the rate of progression of renal insufficiency.
Na osnovi razpoložljivih podatkov zdravljenje anemije z zdravilom Abseamed pri odraslih bolnikih s kronično ledvično odpovedjo (ledvična insuficienca), pri katerih zdravljenje z dializo še ni potrebno, ne pospešuje hitrosti napredovanja ledvične insuficience.
The 2-3 week delay between epoetin alfa administration and the appearance of desired effects should be taken into account when assessing the efficacy of Abseamed.
Pri ocenjevanju učinkovitosti zdravljenja z zdravilom Abseamed je treba upoštevati 2 - do 3- tedenski zamik med začetkom zdravljenja z epoetinom alfa in pojavom želenih učinkov.
Your doctor will check your levels of the red blood pigment (haemoglobin) regularly and adjust your dose of Abseamed accordingly to minimise the risk of blood clotting (thrombotic events).
Zdravnik bo redno preverjal vrednosti rdečega pigmenta v vaši krvi (hemoglobina) in temu ustrezno prilagodil odmerek zdravila Abseamed z namenom zmanjšanja tveganja nastanka krvnih strdkov (trombotični dogodki).
Cancer patients receiving treatment with erythropoietin have an increased risk of blood clots/ blood clotting disorders (thrombotic vascular events).
Pri rakavih bolnikih, ki se zdravijo z eritropoetinom, obstaja večje tveganje za krvne strdke/ motnje v strjevanju krvi (trombotični žilni dogodki).
This risk should be carefully weighted against the benefit to be derived from treatment with epoetin alfa, particularly if you have an increased risk of thrombotic vascular events, e. g. if you are obese or have a history of thrombotic vascular events (e. g. deep vein thrombosis or pulmonary embolism).
To tveganje je treba skrbno pretehtati glede na pričakovano korist zdravljenja z epoetinom alfa, še posebej, če ste izpostavljeni zvečanemu tveganju za trombotične žilne dogodke, na primer če imate čezmerno telesno maso ali ste že preboleli trombotični žilni dogodek (npr. globoko vensko trombozo ali pljučno embolijo).
If you are a cancer patient you should be aware that Abseamed may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Če ste bolnik z rakom, morate vedeti, da lahko zdravilo Abseamed deluje kot celični rastni faktor in da ima lahko v nekaterih razmerah negativen vpliv na vašo bolezen.