natgillin/translations-raw huggingface dataset:
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Točkovna ocena razmerja tveganja metaanalize podatkov stopnje preživetja je bila 1,06 v korist kontrolne skupine (95-% IZ: 1,00; 1,12; 53 preskušanj in 13.933 bolnikov), medtem ko je bila le-ta za bolnike z rakom, ki so prejemali kemoterapijo, enaka 1,04 (95-% IZ: 0,97; 1,11; 38 preskušanj in 10.441 bolnikov).
If you are a patient with chronic renal failure, your doctor will check that a particular blood parameter (haemoglobin) does not exceed a defined threshold.
Anemija, ki jo povzroča kronična ledvična odpoved Če imate kronično ledvično odpoved, bo zdravnik preveril, da poseben krvni parameter (hemoglobin) ne presega opredeljene meje.
- Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.
- Zdravljenje simptomatske anemije, povezane s kronično ledvično odpovedjo, pri odraslih bolnikih.
What Biopoin looks like and contents of the pack
Izgled zdravila Biopoin in vsebina pakiranja
Patients were randomised to continue their current treatment or to be converted to epoetin theta (same dose as epoetin beta) in order to maintain their haemoglobin levels.
Bolnike so naključno razporedili v skupino, ki je nadaljevala trenutno zdravljenje, ali skupino, v kateri so epoetin beta zamenjali z epoetinom theta (enakim odmerkom), da so vzdrževali ravni hemoglobina.
PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including with epoetin theta.
O aplaziji PRCA, ki jo povzročajo nevtralizirajoča protitelesa proti eritropoetinu, so poročali v povezavi z zdravljenjem z eritropoetinom, vključno z epoetinom theta.
EU/1/09/565/025 EU/1/09/565/026 EU/1/09/565/027 EU/1/09/565/028 EU/1/09/565/040 EU/1/09/565/041 EU/1/09/565/042
EU/1/09/565/024 EU/1/09/565/025 EU/1/09/565/026 EU/1/09/565/027 EU/1/09/565/028 EU/1/09/565/040 EU/1/09/565/041 EU/1/09/565/042
Patients on epoetin theta therapy can experience an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase.
Pri bolnikih, ki se zdravijo z epoetinom theta, se lahko pojavi zvišanje krvnega tlaka ali poslabšanje obstoječe hipertenzije, predvsem med začetno fazo zdravljenja.
Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched.
Tekočino v tkivo iztisnite počasi in enakomerno, pri čemer naj bo koža ves čas med palcem in kazalcem.
Epoetin theta is identical in its amino acid sequence and similar in its carbohydrate composition (glycosylation) to endogenous human erythropoietin.
Sekvenca aminokislin epoetina theta je enaka kot pri endogenem humanem eritropoetinu, sestava ogljikovih hidratov (glikozilacija) pa podobna.
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva artralgija
≥ 1/100 to < 1/10;
≥ 1/100 do < 1/10
Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Rezultata splošnega preživetja v skupinah ni bilo mogoče zadovoljivo pojasniti z razlikami v incidenci tromboze in povezanih zapletov med bolniki, ki so se zdravili z rekombinantnim humanim eritropoetinom, in bolniki v kontrolnih skupinah.
In patients with a poor haemoglobin response to epoetin theta, alternative explanations for the poor response should be considered (see sections 4.4 and 5.1).
Pri bolnikih s slabim odzivom hemoglobina na epoetin theta je treba razmisliti o možnih drugih razlagah za slab odziv (glejte poglavji 4.4 in 5.1).
If you develop a serious rash or another of these skin symptoms, stop using Biopoin and contact your doctor or seek medical attention immediately.
Če se je pri vas pojavil hud izpuščaj ali eden od teh kožnih simptomov, prenehajte z uporabo zdravila Biopoin in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
The solution can be administered subcutaneously or intravenously.
Raztopina se lahko uporablja subkutano ali intravensko.
If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in picture 7).
Če injiciranje opravlja druga oseba, lahko uporabi tudi zadnji in stranski del nadlakti (glejte siva območja na sliki 7).
In the case of injections under the skin, the weekly dose can be given either as 1 injection per week or as 3 divided injections per week.
Pri injiciranju pod kožo se lahko tedenski odmerek daje kot 1 injekcijo na teden ali 3 injekcije na teden.
Do not remove the needle cover at this time.
Ne odstranite še pokrovčka za iglo.
This medicine is given as an injection using a pre-filled syringe.
To zdravilo se injicira z napolnjeno injekcijsko brizgo.
There are flaps at the end of the needle bag.
Na koncu vrečke za iglo so jezički.
Your blood pressure needs to be checked closely before and during treatment with this medicine.
Pred zdravljenjem s tem zdravilom in med njim je treba skrbno spremljati krvni tlak.
Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.
Pomožne snovi: natrijev dihidrogenfosfatdihidrat, natrijev klorid, polisorbat 20, trometamol, klorovodikova kislina (6 M) (za uravnavanje pH), voda za injekcije.
Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life.
Sedem dni se lahko shranjuje pri sobni temperaturi (ne nad 25 °C), vendar ne po izteku roka uporabnosti.
You may remove Biopoin from the refrigerator and store it not above 25 °C for a single period of up to 7 days without exceeding the expiry date.
Zdravilo Biopoin lahko vzamete iz hladilnika in ga do sedem dni shranjujete na temperaturi do 25 °C, pri čemer mu ne sme preteči rok uporabnosti.
A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing.
Paradoksalno zvišanje hemoglobina in razvoj hude anemije, povezane s številom retikulocitov, je razlog za takojšnjo ukinitev zdravljenja z epoetinom in preiskavo prisotnosti protiteles proti eritropoetinu.
You may notice small air bubbles in the pre-filled syringe.
V napolnjeni injekcijski igli boste morda opazili zračne mehurčke.
Table 1: Adverse reactions System organ class
Preglednica 1: Neželeni učinki Organski sistem Neželeni učinek
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
da si ne poskušate injicirati zdravila, če vas zdravnik ali medicinska sestra za to nista posebej usposobila.
Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched (see picture 11).
Tekočino v tkivo iztisnite počasi in enakomerno, pri čemer naj bo koža ves čas med palcem in kazalcem (glejte sliko 11).
If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in picture 6).
Če injiciranje opravlja druga oseba, lahko uporabi tudi zadnji in stranski del nadlakti (glejte siva območja na sliki 6).
Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 8).
Z alkoholnim čistilnim robčkom razkužite mesto injiciranja ter kožo primite med palcem in kazalcem, ne da bi jo ob tem stisnili (glejte sliko 8).
Erythropoietin is produced in your kidneys and stimulates your bone marrow to produce red blood cells.
Eritropoetin se tvori v ledvicah in spodbuja tvorbo rdečih krvničk v kostnem mozgu.
The pre-filled syringes are for single use only.
Napolnjene injekcijske brizge namenjene samo enkratni uporabi.
≥ 1/10,000 to < 1/1,000;
≥ 1/10.000 do < 1/1000
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, aluminium intoxication, underlying haematological diseases or bone marrow fibrosis may also compromise the erythropoietic response.
Eritropoetski odziv lahko ogrozijo tudi interkurentne okužbe, vnetne ali travmatske epizode, okultna izguba krvi, hemoliza, zastrupitev z aluminijem, osnovne hematološke bolezni ali fibroza kostnega mozga.
Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 7).
Z alkoholnim čistilnim robčkom razkužite mesto injiciranja ter kožo primite med palcem in kazalcem, ne da bi jo ob tem stisnili (glejte sliko 7).
Discontinuation of treatment with epoetin theta should be taken into account.
Treba je pretehtati možnost prekinitve zdravljenja z epoetinom theta.
In cancer patients with non-myeloid malignancies receiving chemotherapy epoetin theta should be administered by the subcutaneous route only.
Pri bolnikih z nemieloidnimi malignostmi, ki prejemajo kemoterapijo, se lahko epoetin theta daje samo subkutano.
Biopoin contains sodium
Zdravilo Biopoin vsebuje natrij
Subcutaneous administration
Subkutana uporaba
The haemoglobin values in your blood should not exceed a value of 12 g/dl (7.45 mmol/l).
Vrednosti hemoglobina v krvi ne smejo preseči 12 g/dl (7,45 mmol/l).
If the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l) a doubling of the weekly dose to 40,000 IU should be considered.
Če se vrednost hemoglobina ni povečala za vsaj 1 g/dl (0,62 mmol/l), je treba razmisliti o podvojitvi odmerka na 40.000 i.e.
Symptoms of influenza-like illness such as fever, chills and asthenic conditions have been reported.
Poročali so tudi o simptomih bolezni, podobnih gripi, kot so zvišana telesna temperatura, mrzlica in astenična stanja.
The maximum dose should not exceed 60,000 IU per week.
Največji odmerek ne sme preseči 60.000 i.e. na teden.
Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy 409 cancer patients receiving chemotherapy were included in two prospective, randomised double-blind, placebo-controlled studies.
409 bolnikov z rakom, ki so prejemali kemoterapijo, so vključili v dve prospektivni, randomizirani,
Anaemia caused by chronic renal failure
Anemija, ki jo povzroča kronična ledvična odpoved
≥ 1/1,000 to < 1/100;
≥ 1/1000 do < 1/100
In the clinical studies, pre-dialysis patients were treated once-weekly with epoetin theta, 174 patients in the maintenance phase study and 111 patients in the long-term study.
174 bolnikov v študiji vzdrževalne faze in 111 bolnikov v dolgotrajni študiji.
For both routes of administration, the maximum dose should not exceed 700 IU/kg body weight per week.
Pri obeh poteh uporabe največji odmerek ne sme preseči 700 i.e./kg telesne mase na teden.
Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in napolnjeni injekcijski brizgi poleg oznake Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Hypertensive crisis*
Žilne bolezni hipertenzija*
In two long-term studies, the efficacy of epoetin theta was evaluated in 124 haemodialysis patients and 289 patients not yet undergoing dialysis.
V dveh dolgotrajnih študijah so učinkovitost epoetina theta ocenili pri 124 bolnikih na hemodializi in
Take one blister with a pre-filled syringe out of the refrigerator.
Iz hladilnika vzemite en pretisni omot z napolnjeno injekcijsko brizgo.
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na napolnjeno injekcijsko brizgo, kar v bistvu pomeni ‘brez natrija'.
Please speak with your doctor if you belong to one of these patient groups: - patients with liver problems, - patients with pathological changes in their red blood cells (homozygous sickle cell anaemia).
Posvetujte se z zdravnikom, če spadate v eno od naslednjih skupin bolnikov: - bolniki s težavami z jetri,
Epoetin theta should be administered either subcutaneously or intravenously in order to increase haemoglobin level to not greater than 12 g/dl (7.45 mmol/l).
Epoetin theta je treba dajati subkutano ali intravensko, da zvišanje ravni hemoglobina ne preseže 12 g/dl (7,45 mmol/l).
If, after 12 weeks of therapy, the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), response is unlikely and treatment should be discontinued.
Če se po 12 tednih zdravljenja vrednost hemoglobina ne poveča za vsaj 1 g/dl (0,62 mmol/l), odziv ni verjeten, zato je treba zdravljenje prekiniti.
For instructions on how to inject the medicinal product, see package leaflet.
Za navodila o injiciranju zdravila glejte navodilo za uporabo.
Some of the information required for using the pre-filled syringe can be found at the end of this package leaflet (see section “7.
Nekaj informacij o uporabi napolnjene injekcijske igle je na koncu teh navodil za uporabo (glejte poglavje »Informacije o samostojnem injiciranju«).
In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
Pri teh bolnikih k anemiji pomembno prispevata pomanjkanje eritropoetina in zmanjšan odziv eritroidnih progenitorskih celic na endogeni eritropoetin.
A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four week period should be avoided.
Treba se je izogibati povečanju vrednosti hemoglobina za več kot 2 g/dl (1,24 mmol/l), v štirih tednih.
Where your injection should be given
Kam si morate injicirati zdravilo
Press the injection site with a piece of gauze bandage or a sterile gauze swab for several seconds.
Na mesto injiciranja za več sekund pritisnite košček povoja iz gaze ali sterilno vatno blazinico.
Remove the tip cap from the pre-filled syringe (see picture 2).
Z napolnjene injekcijske brizge odstranite vrhnjo zaporko (glejte sliko 2).
If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current dose should be continued.
Če se po 4 tednih zdravljenja vrednost hemoglobina poveča za vsaj 1 g/dl (0,62 mmol/l), je treba nadaljevati s trenutnim odmerkom.
Attach the needle to the syringe (see picture 3).
Na brizgo pritrdite iglo (glejte sliko 3).
Information for injecting yourself
Informacije za samostojno injiciranje
Biopoin 10,000 IU/1 ml, Biopoin 20,000 IU/1 ml and Biopoin 30,000 IU/1 ml: Each pre-filled syringe contains 1 ml of solution.
Biopoin 10.000 i.e./1 ml, Biopoin 20.000 i.e./1 ml in Biopoin 30.000 i.e./1 ml: ena napolnjena injekcijska brizga vsebuje 1 ml raztopine.
If you have hardening of the blood vessels in your kidneys (nephrosclerosis) but do not need to undergo dialysis, your doctor will consider whether treatment is suitable for you.
Če so krvne žile v ledvicah otrdele (nefroskleroza), vendar ne potrebujete dialize, bo zdravnik pretehtal, ali je to zdravljenje primerno za vas, saj ni mogoče zagotovo izključiti morebitne pospešitve napredovanja ledvične bolezni.
Dispose of syringes with a safety device as instructed by your doctor, pharmacist or nurse.
Injekcijske brizge z varnostnim pripomočkom odstranite skladno z navodili zdravnika, farmacevta ali medicinske sestre.
Biopoin 1,000 IU/0.5 ml, Biopoin 2,000 IU/0.5 ml, Biopoin 3,000 IU/0.5 ml, Biopoin 4,000 IU/0.5 ml and Biopoin 5,000 IU/0.5 ml: Each pre-filled syringe contains 0.5 ml of solution.
Biopoin 1000 i.e./0,5 ml, Biopoin 2000 i.e./0,5 ml, Biopoin 3000 i.e./0,5 ml, Biopoin 4000 i.e./0,5 ml in Biopoin 5000 i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 0,5 ml raztopine.
If typical causes of non-response are excluded, and the patient has a sudden drop in haemoglobin associated with reticulocytopenia, an examination of anti-erythropoietin antibodies and the bone marrow for diagnosis of pure red cell aplasia should be considered.
Čista aplazija rdečih krvničk (PRCA) Če ste izključili značilne vzroke neodzivnosti in se je pri bolniku pojavilo nenadno zmanjšanje hemoglobina, povezano z retikulocitopenijo, je treba razmisliti o preiskavi protiteles proti eritropoetinu in kostnega mozga za diagnosticiranje čiste aplazije rdečih krvničk.
Non-clinical data with epoetin theta reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Predklinični podatki za epoetin theta na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
Symptomatic anaemia associated with chronic renal failure
Simptomatska anemija, povezana s kronično ledvično odpovedjo
In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and
Pri bolnikih s slabim odzivom hemoglobina na epoetin theta je treba razmisliti o možnih drugih razlagah za slab odziv (glejte poglavji 4.2 in 5.1).
Depending on your individual situation a blood transfusion may be preferable.
Morda bo boljša krvna transfuzija, kar je odvisno od vašega stanja kot posameznika.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja kožne reakcije*
To give yourself an injection into the tissue under the skin you will need: - a pre-filled syringe of Biopoin, - an alcohol wipe, - a piece of gauze bandage or a sterile gauze swab, - a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely.
- alkoholni čistilni robček, - košček povoja iz gaze ali sterilno vatno blazinico, - vsebnik, odporen proti vbodom (plastični vsebnik, ki ga dobite v bolnišnici ali lekarni), da lahko varno zavržete uporabljene brizge.
Open the blister and take the pre-filled syringe and the needle container out of the blister.
Odprite pretisni omot in napolnjeno injekcijsko brizgo in vsebnik za iglo vzemite iz pretisnega omota.
Non-response to therapy with epoetin theta should prompt a search for causative factors.
Če se bolnik ne odziva na zdravljenje z epoetinom theta, je treba poiskati vzročne dejavnike.
Open the blister and take the pre-filled syringe and the needle bag out of the blister.
Odprite pretisni omot in napolnjeno injekcijsko brizgo in vrečko za iglo vzemite iz pretisnega omota.
The dose should be adjusted as necessary to maintain the individual target haemoglobin level between 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l), whereby a haemoglobin level of 12 g/dl (7.45 mmol/l) should not be exceeded.
Po potrebi je treba odmerek prilagoditi, da se pri posamezniku vzdržuje ciljna raven hemoglobina od 10 g/dl (6,21 mmol/l) do 12 g/dl (7,45 mmol/l), pri čemer pa se ne sme preseči raven hemoglobina
Erythropoietin is a growth factor that primarily stimulates red cell production.
Epoetin alfa je rastni faktor, ki primarno stimulira tvorbo rdečih krvničk.
Stop using Biopoin if you develop these symptoms and contact your doctor or seek medical attention immediately.
Če se pri vas pojavijo ti simptomi, prenehajte uporabljati zdravilo Biopoin in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
How to use Biopoin
Kako uporabljati zdravilo Biopoin
Biopoin contains the active substance epoetin theta, which is almost identical to erythropoietin, a natural hormone produced by your body.
Zdravilo Biopoin vsebuje zdravilno učinkovino epoetin theta, ki je skoraj enaka eritropoetinu,
Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
poslabšana hoja) in povezanimi zapleti (epileptični napadi, kap) se lahko pojavijo tudi pri posameznikih, pri katerih je krvni tlak drugače normalen ali nizek (glejte poglavje 4.4).
- Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
- Zdravljenje simptomatske anemije pri odraslih rakavih bolnikih z nemieloidnimi malignostmi, ki prejemajo kemoterapijo.
Epoetins are not approved in the management of anaemia associated with hepatitis C.
Epoetini niso odobreni za zdravljenje anemije,
Each pre-filled syringe is for single use only.
Ena napolnjena injekcijska brizga je samo za enkratno uporabo.
Do not use this medicine if you notice it is cloudy or there are particles in it. Do not throw away any medicines via wastewater or household waste.
Ne uporabljajte tega zdravila, če opazite, da je motno ali so v njem delci.
In reproductive toxicity studies performed with other epoetins, effects interpreted as being secondary to decreased maternal body weight were observed at doses sufficiently in excess to the recommended human dose.
zadostno večjih od priporočenega odmerka pri človeku, opazili učinke, ki so jih pripisali zmanjšani telesni masi matere.
This leaflet was last approved in .
Navodilo je bilo odobreno.
Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy
Simptomatska anemija pri rakavih bolnikih z nemieloidnimi malignostmi, ki prejemajo kemoterapijo
Intravenous administration: The initial posology is 40 IU/kg body weight 3 times per week.
Intravenska uporaba: začetno odmerjanje je 40 i.e./kg telesne mase 3-krat na teden.
Caution should be exercised with escalation of epoetin theta doses in patients with chronic renal failure.
Pri zviševanju odmerkov epoetina theta bolnikom s kronično ledvično odpovedjo je potrebna pozornost.
General
Splošne
Further increases of 25% of the previous dose may be made at monthly intervals until the individual target haemoglobin level is obtained.
Dokler se pri posamezniku ne doseže ciljna raven hemoglobina, se lahko odmerek povečuje za 25 % v mesečnih presledkih.
Common (may affect up to 1 in 10 people) - Headache; - High blood pressure; - Flu-like symptoms, such as fever, chills, feeling of weakness, tiredness; - Skin reactions, such as rash, itching or reactions around the injection site.
- simptomi, podobni gripi, kot so zvišana telesna temperatura, občutek šibkosti, utrujenost; - kožne reakcije, kot so izpuščaj, srbenje ali reakcije okoli mesta injiciranja.
How Biopoin is used
Kako se uporablja zdravilo Biopoin
Subcutaneous administration: The initial posology is 20 IU/kg body weight 3 times per week.
Subkutana uporaba: začetno odmerjanje je 20 i.e./kg telesne mase 3-krat na teden.
The maximum dose should not exceed 700 IU/kg body weight per week.
Največji odmerek ne sme presegati 700 i.e./kg telesne mase na teden.
In patients with chronic renal failure, neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with epoetin theta therapy has been reported in post marketing setting.
Pri posameznih bolnikih s kronično ledvično odpovedjo so v obdobju trženja zdravila poročali o čisti aplaziji rdečih krvničk (PRCA - pure red cell aplasia), ki so jo sprožila nevtralizirajoča protitelesa proti eritropoetinu, in je bila povezana z zdravljenjem z epoetinom theta.
The dose of Biopoin (expressed in International Units or IU) depends on your disease condition, your body weight and the way the injection is given (under the skin [subcutaneous injection] or into a vein [intravenous injection]).
telesne mase in načina injiciranja (pod kožo [subkutano injiciranje] ali v veno [intravensko injiciranje]).
The initial dose for injections under the skin is 20 IU per kg of bodyweight, given 3 times per week.
Začetni odmerek za injiciranje pod kožo je 20 i.e. na kg telesne mase trikrat na teden.
An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06; 35 trials and 6,769 patients) was observed in patients treated with recombinant human erythropoietin.
Pri bolnikih, ki so se zdravili z rekombinantnim humanim eritropoetinom, so opazili povečano relativno tveganje trombemboličnih dogodkov (RT 1,67, 95-odstotni IZ: 1,35, 2,06; 35 preskušanj in