natgillin/translations-raw huggingface dataset:
Your Epoetin alfa HEXAL dose and frequency of administration may be further adjusted to maintain your response to treatment.
Dodatno Vam može prilagoditi dozu i učestalost primjene Epoetin alfa HEXALa kako bi se održao odgovor na liječenje.
• The recommended dose is 600 IU per kilogram body weight once a week.
• Preporučena doza je 600 IU po kilogramu tjelesne težine jednom tjedno.
All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.
Potrebno je razmotriti sve druge uzroke anemije (nedostatak željeza, folata ili vitamina B12, trovanje aluminijem, infekcija ili upala, gubitak krvi, hemoliza i fibroza koštane srži bilo kojeg porijekla)
Epoetin alfa was evaluated in an open-label, non-randomised, open dose-range, 52-week clinical study in paediatric CRF patients undergoing haemodialysis.
Kronično zatajenje bubrega Epoetin alfa ocijenjen je u otvorenom, nerandomiziranom kliničkom ispitivanju otvorenog raspona doza koje je trajalo 52 tjedna u pedijatrijskih bolesnika s KZB na hemodijalizi.
Cancer patients being treated with epoetin alfa should have haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter.
Onkološkim bolesnicima koji se liječe epoetinom alfa potrebno je redovito mjeriti razinu hemoglobina sve dok ne postignu stabilnu razinu, te povremeno nakon toga.
Epoetin alfa HEXAL is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤ 10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/mL).
≤ 10 g/dl) u odraslih s primarnim mijelodisplastičnim sindromom (MDS) niskog ili srednjeg-1 rizika koji imaju niski serumski eritropoetin (< 200 mU/ml).
- For patients in an autologous predonation programme, iron supplementation (elemental iron 200 mg/day orally) should be administered several weeks prior to initiating the autologous predeposit in order to achieve high iron stores prior to starting epoetin alfa therapy, and throughout the course of epoetin alfa therapy.
200 mg/dan peroralno) treba se primijeniti nekoliko tjedana prije početka autologne pohrane kako bi se postigle velike zalihe željeza prije početka i tijekom terapije epoetinom alfa.
Patients treated with epoetin alfa were also able to predeposit significantly more units of blood (epoetin alfa 300 IU/kg = 4.4 units; epoetin alfa 600 IU/kg = 4.7 units) than placebo-treated patients (2.9 units).
300 IU/kg = 4,4 jedinice; epoetin alfa 600 IU/kg = 4,7 jedinica) nego bolesnici liječeni placebom (2,9 jedinica).
• if there has been a refrigerator failure.
• ako je hladnjak u kojem se čuvao lijek bio u kvaru.
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.
Pomoćne tvari: natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, glicin, polisorbat 80, kloridna kiselina (za podešavanje pH), natrijev hidroksid (za podešavanje pH) i voda za injekcije.
erythropoietin suggested that distribution volume was approximately 1.5 to 2 times higher in the preterm neonates than in the healthy adults, and clearance was approximately 3 times higher in the preterm neonates than in healthy adults.
Ispitivanje u 7 prijevremeno rođene novorođenčadi s vrlo niskom porođajnom težinom i 10 zdravih odraslih koji su primili i.v. eritropoetin pokazalo je da je volumen distribucije bio približno 1,5 do 2 puta veći u prijevremeno rođene novorođenčadi nego u zdravih odraslih, a klirens je bio približno
Chronic renal failure patients being treated with epoetin alfa should have haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter.
Bolesnicima s kroničnim zatajenjem bubrega koji se liječe epoetinom alfa potrebno je redovito mjeriti razinu hemoglobina sve dok se ne postigne stabilna razina, te povremeno nakon toga.
Additional studies compared the 40,000 IU once-weekly regimen of epoetin alfa with biweekly doses ranging from 80,000 to 120,000 IU subcutaneously.
40 000 IU epoetina alfa jednom tjedno i doze u rasponu od 80 000 do 120 000 IU primjenjene supkutano jednom u dva tjedna.
Epoetin alfa HEXAL should be administered to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dL (6.2 mmol/L)).
Epoetin alfa HEXAL treba primijeniti u bolesnika s anemijom (npr. koncentracija hemoglobina ≤ 10 g/dl (6,2 mmol/l)).
An increase in heparin dose during haemodialysis is frequently required during the course of therapy with epoetin alfa as a result of the increased packed cell volume.
Zbog povišenja hematokrita za vrijeme terapije epoetinom alfa često je potrebno povisiti dozu heparina tijekom hemodijalize.
Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4).
Neophodno je praćenje krvnog tlaka, osobito na početku terapije
Epoetin alfa HEXAL should be administered in order to increase haemoglobin to not greater than 11 g/dL (6.8 mmol/L).
Epoetin alfa HEXAL treba primjenjivati kako bi se razina hemoglobina povisila do najviše 11 g/dl (6,8 mmol/l).
In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name and the batch number of the administered ESA should be clearly recorded (or stated) in the patient file.
Radi poboljšanja sljedivosti lijekova za stimulaciju eritropoeze, u medicinskoj dokumentaciji bolesnika treba pažljivo zabilježiti (ili navesti) zaštićeni naziv i broj serije primijenjenog lijeka za stimulaciju eritropoeze.
• the seal is broken.
• je pakiranje oštećeno.
Anti-erythropoietin antibody positive
Pretrage pozitivna anti-eritropoetinska protutijela rijetko
“Instructions on how to inject Epoetin alfa HEXAL yourself” can be found at the end of the package leaflet.
„Upute za samostalnu primjenu injekcije Epoetin alfa HEXAL” mogu se pronaći na kraju upute o lijeku.
Epoetin alfa HEXAL should be administered in order to increase haemoglobin to not greater than 12 g/dL (7.5 mmol/L).
Epoetin alfa HEXAL treba primjenjivati kako bi se hemoglobin povisio na razinu koja nije viša od 12 g/dl (7,5 mmol/l).
In addition, there was no statistical difference between the proportion of patients requiring pRBC transfusions between the Epoetin alfa group and placebo.
Uz to, nije bilo statističke razlike između skupine liječene epoetinom alfa i placebom u udjelu bolesnika kojima su bile potrebne transfuzije crvenih krvnih stanica.
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva osip često urtikarija3
Treatment of patients with chemotherapy-induced anaemia
Liječenje bolesnika s anemijom induciranom kemoterapijom
Antibody-mediated PRCA has been reported after months to years of epoetin alfa treatment.
Izolirana aplazija crvene loze posredovana protutijelima prijavljena je nakon više mjeseci ili godina liječenja epoetinom alfa.
Pre-filled syringe without needle safety guard
Primjena napunjene štrcaljke bez sigurnosnog štitinika za iglu
In paediatric patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration of Epoetin alfa HEXAL by the intravenous route is preferable.
U pedijatrijskih bolesnika s kroničnim zatajenjem bubrega u kojih je rutinski dostupan intravenski pristup (bolesnici na hemodijalizi) preferira se primjena lijeka Epoetin alfa HEXAL intravenskim putem.
Chemotherapy-induced anaemia
Anemija inducirana kemoterapijom
From pretreatment to presurgery, the mean increase in haemoglobin in the 600 IU/kg weekly group (1.44 g/dL) was twice than that observed in the 300 IU/kg daily group (0.73 g/dL).
Srednja vrijednost porasta razine hemoglobina od razine prije liječenja do razine prije operacije bila je dvostruko veća u skupini koja je primala 600 IU/kg epoetina alfa tjedno (1,44 g/dl) nego u skupini koja je primala 300 IU/kg epoetina alfa dnevno (0,73 g/dl).
In patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration of Epoetin alfa HEXAL by the intravenous route is preferable.
U bolesnika s kroničnim zatajenjem bubrega u kojih je rutinski dostupan intravenski pristup (bolesnici na hemodijalizi) preferira se primjena lijeka Epoetin alfa HEXAL intravenskim putem.
In the 20-week study (n = 225), no significant difference was observed in the primary efficacy endpoint, i.e. the proportion of patients who required a RBC transfusion after Day 28 (62% of epoetin alfa patients versus 69% of standard therapy patients).
U 20-tjednom ispitivanju (N = 225) nije bila opažena značajna razlika u primarnom ishodu djelotvornosti, tj. udjelu bolesnika kojima je bila potrebna transfuzij crvenih krvnih stanica nakon
The median time to progression (TTP) based on investigator-determined progressive disease (PD) was 7.5 months in the epoetin alfa plus SOC group and 7.5 months in the SOC group (HR 1.099, 95% CI: 0.998, 1.210).
Medijan vremena do progresije temeljen na ispitivačevoj ocjeni progresivne bolesti bio je 7,5 mjeseci u skupini liječenoj epoetinom alfa plus standardna terapija i 7,5 mjeseci u skupini liječenoj standardnom terapijom (HR 1,099, 95 % CI:
Do not shake Epoetin alfa HEXAL syringes.
Nemojte tresti štrcaljke Epoetin alfa HEXAL.
Chills, Influenza like illness, Injection site reaction, Oedema peripheral
Opći poremećaji i reakcije na mjestu primjene pireksija vrlo često zimica, bolest nalik gripi, reakcija na mjestu injekcije, periferni edemi često nedjelotvornost lijeka3
The safety of epoetin alfa has not been established in patients with hepatic dysfunction.
Sigurnost epoetina alfa u bolesnika s poremećajem funkcije jetre nije ustanovljena.
• Store and transport refrigerated (2°C-8°C).
• Čuvati i prevoziti na hladnom (2 °C - 8 °C).
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially “sodium-free”.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po napunjenoj štrcaljki, tj. zanemarive količine natrija.
• The starting dose is 450 IU per kilogram bodyweight once a week.
• Početna doza je 450 IU po kilogramu tjelesne težine jednom tjedno.
The starting dose is 50 IU/kg, 3 times per week.
Početna doza je 50 IU/kg, 3 puta tjedno
The product is for single use only.
Lijek je namijenjen za jednokratnu primjenu.
Store and transport refrigerated (2°C-8°C).
Čuvati i prevoziti na hladnom (2 °C-8 °C).
In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis).
(4,7 %) kod ispitanika je došlo do TVD-a (iznenadna smrt, ishemijski moždani udar, embolija i flebitis).
The safety and efficacy of epoetin alfa in chronic renal failure patients with anaemia before initiation of dialysis or on peritoneal dialysis have not been established.
Anemija u bolesnika s kroničnim zatajenjem bubrega prije započinjanja dijalize ili na peritonealnoj dijalizi Sigurnost i djelotvornost epoetina alfa u bolesnika s kroničnim zatajenjem bubrega i anemijom prije započinjanja dijalize ili na peritonealnoj dijalizi nisu ustanovljene.
If the haemoglobin concentration is increasing by more than 2 g/dL (1.25 mmol/L) per month, or if the haemoglobin concentration level exceeds 12 g/dL (7.5 mmol/L), reduce the Epoetin alfa HEXAL dose by about 25 to 50%.
Ako se koncentracija hemoglobina povećava za više od 2 g/dl (1,25 mmol/l) na mjesec, ili koncentracija hemoglobina prijeđe 12 g/dl (7,5 mmol/l), smanjite dozu Epoetin alfa HEXALa za oko 25 do 50 %.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
Appropriate adjustment of the dose should be made in order to maintain haemoglobin levels within the desired concentration range between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L).
Potrebno je učiniti odgovarajuću prilagodbu doze radi održavanja vrijednosti hemoglobina unutar željenog raspona koncentracije između 9,5 g/dl i 11 g/dl (5,9 i 6,8 mmol/l).
Immune system disorders
Poremećaji imunološkog sustava preosjetljivost3
Do not use Epoetin alfa HEXAL:
Nemojte primjenjivati Epoetin alfa HEXAL:
A haemoglobin concentration of greater than 12 g/dL (7.5 mmol/L) should be avoided.
Koncentracija hemoglobina veća od 12 g/dl (7,5 mmol/l) treba se izbjegavati.
Starting dose of 50 IU/kg, 3 times per week, followed if necessary by a dosage increase with 25 IU/kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
25 IU/kg (3 puta tjedno) do postizanja željenog cilja (to treba učiniti u razmacima od najmanje četiri tjedna).
An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.8).
Opažena je povećana incidencija trombotskih vaskularnih događaja (TVD) u bolesnika koji primaju lijekove za stimulaciju eritropoeze (vidjeti dio 4.8).
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Epoetin alfa HEXAL, treatment with Epoetin alfa HEXAL must not be restarted in this patient at any time.
U slučaju da se zbog primjene Epoetin alfa HEXALa u bolesnika pojave teške kožne reakcije kao što su Stevens-Johnsonov sindrom ili toksična epidermalna nekroliza, ni u jednom trenutku ne smije se ponovno započeti liječenje tog bolesnika lijekom Epoetin alfa HEXAL.
A sustained haemoglobin level of greater than 12 g/dL (7.5 mmol/L) should be avoided.
Održavanje razine hemoglobina iznad 12 g/dl (7,5 mmol/l) treba izbjegavati.
Epoetin alfa HEXAL contains sodium
Epoetin alfa HEXAL sadrži natrij
Treatment of paediatric patients scheduled for major elective orthopaedic surgery
Liječenje pedijatrijskih bolesnika predviđenih za veliki elektivni ortopedski kirurški zahvat
Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reactions, and angioneurotic oedema have been reported (see section 4.4).
anafilaktičke reakcije i angioneurotskog edema (vidjeti dio 4.4).
Adults on chemotherapy
Odrasli koji primaju kemoterapiju
Patients with CRF not on dialysis demonstrated a dose-dependent and sustained increase in haematocrit when epoetin alfa was administered by either an intravenous or subcutaneous route.
Bolesnici s KZB koji nisu na dijalizi su, pri primjeni epoetina alfa bilo intravenski bilo supkutanim putem, pokazali ravnomjeran porast hematokrita ovisan o dozi.
A defined concentration-time profile with peak and return to baseline was observed for changes in percent reticulocytes.
Uočen je definirani profil krivulje koncentracija-vrijeme s vrhom porasta postotka retikulocita te povratkom na početnu vrijednost.
If the haemoglobin is rising by more than 2 g/dL (1.25 mmol/L) per month, or if the sustained haemoglobin exceeds 12 g/dL (7.5 mmol/L) reduce the Epoetin alfa HEXAL dose by 25%.
Ako razina hemoglobina raste za više od 2 g/dl (1,25 mmol/l) na mjesec ili ako razina hemoglobina kontinuirano prelazi 12 g/dl (7,5 mmol/l) smanjite dozu Epoetin alfa HEXALa za 25 %.
Anaphylactic reaction3
manje često anafilaktička reakcija3
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
U ovih bolesnika se preporučuje rana revizija arteriovenskog spoja i profilaksa tromboze, na primjer, primjenom acetilsalicilatne kiseline.
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane hiperkalijemija1
An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.4).
Opažena je povećana incidencija trombotskih vaskularnih događaja (TVD) u bolesnika koji primaju lijekove za stimulaciju eritropoeze (vidjeti dio 4.4).
The recommended desired haemoglobin concentration range is between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Preporučeni željeni raspon koncentracije hemoglobina je između 10 g/dl i 12 g/dl (6,2 i 7,5 mmol/l).
Instructions on how to inject yourself with Epoetin alfa HEXAL can be found at the end of this leaflet.
Upute za samostalnu primjenu injekcije Epoetin alfa HEXAL nalaze se na kraju ove upute.
In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e.g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales: Functional Assessment of Cancer Therapy-Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
U prospektivnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju provedenom u 375 anemičnih bolesnika s različitim nemijeloidnim zloćudnim bolestima koji su primali kemoterapiju bez platine postojalo je značajno sniženje posljedica povezanih s anemijom (npr.
Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride
POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid,
If the haemoglobin exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinstitute Epoetin alfa HEXAL therapy at a dose 25% below the previous dose.
Ako razina hemoglobina prijeđe 13 g/dl (8,1 mmol/l), prekinite terapiju sve dok razina hemoglobina ne padne ispod 12 g/dl (7,5 mmol/l) i potom ponovno uvedite terapiju Epoetin alfa HEXALom u dozi koja je 25 % manja od prethodne doze.
- If the haemoglobin concentration increase is < 1 g/dL (< 0.62 mmol/L) and the reticulocyte count has increased < 40,000 cells/µL above baseline, increase the dose to 300 IU/kg 3 times per week.
- Ako je koncentracija hemoglobina povećana za < 1 g/dl (< 0,62 mmol/l) i broj retikulocita povećan za < 40 000 stanica/µl iznad početne vrijednosti, dozu povisite na 300 IU/kg 3 puta tjedno.
Take special care with Epoetin alfa HEXAL:
Potreban je poseban oprez pri primjeni lijeka Epoetin alfa HEXAL:
The erythropoietic response observed in both treatment groups resulted in similar transfusion rates (16% in the 600 IU/kg weekly group and 20% in the 300 IU/kg daily group).
Eritropoetski odgovor uočen u obje terapijske skupine rezultirao je sličnim stopama transfuzije (16 %
In cancer patients receiving chemotherapy, the 2 to 3 week delay between ESA administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if epoetin alfa therapy is appropriate (patient at risk of being transfused).
Kada se procjenjuje je li terapija epoetinom alfa prikladna (bolesnik u kojeg postoji rizik od primanja transfuzije) u onkoloških bolesnika koji primaju kemoterapiju, treba uzeti u obzir vremenski razmak od 2 do 3 tjedna između primjene lijekova za stimulaciju eritropoeze i pojave crvenih krvnih stanica induciranih eritropoetinom.
If you are a patient with chronic renal failure, and particularly if you do not respond properly to Epoetin alfa HEXAL, your doctor will check your dose of Epoetin alfa HEXAL because repeatedly increasing your dose of Epoetin alfa HEXAL if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
HEXALa jer opetovano povećavanje doze Epoetin alfa HEXALa ako ne odgovarate na liječenje, može povećati rizik od tegoba sa srcem ili krvnim žilama te može povećati rizik od srčanog udara,
Paediatric patients with very low initial haemoglobin (< 6.8 g/dL or < 4.25 mmol/L) may require higher maintenance doses than patients whose initial haemoglobin is higher (> 6.8 g/dL or > 4.25 mmol/L).
< 4,25 mmol/l) mogu biti potrebne više doze održavanja nego bolesnicima čija je početna vrijednost hemoglobina viša (> 6,8 g/dl ili > 4,25 mmol/l).
If the haemoglobin concentration level exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinitiate Epoetin alfa HEXAL therapy at a dose 25% below the previous dose.
Ako koncentracija hemoglobina prelazi 13 g/dl (8,1 mmol/l), prekinite terapiju sve dok vrijednost ne padne ispod 12 g/dl (7,5 mmol/l) i zatim ponovno uvedite terapiju Epoetin alfa HEXALom u dozi koja je 25 % niža od prethodne.
• feeling dizzy,
• osjećaj omaglice,
How to store Epoetin alfa HEXAL
Kako čuvati Epoetin alfa HEXAL
Patients should only be switched from one ESA to another under appropriate supervision.
Bolesnicima se jedan lijek za stimulaciju eritropoeze smije zamijeniti drugim samo uz odgovarajući nadzor.
In paediatric patients on haemodialysis where intravenous access is readily available, administration by the intravenous route is preferable.
U pedijatijskih bolesnika na hemodijalizi u kojih je lako dostupan intravenski pristup, preferira se primjena intravenskim putem.
The starting dose is 50 IU/kg, 2 times per week.
Faza korekcije Početna doza je 50 IU/kg, 2 puta tjedno.
In studies to explore extending the dosing interval (40,000 IU once weekly and 80,000, 100,000, and 120,000 IU biweekly), a linear but non-dose-proportional relationship was observed between mean Cmax and dose, and between mean AUC and dose at steady state.
100 000 i 120 000 IU jednom u 2 tjedna) uočeno je da je odnos između srednje vrijednosti Cmax i doze te srednje vrijednosti AUC i doze u stanju ravnoteže linearan, ali ne i proporcionalan dozi.
Reticulocyte count increase ≥ 40,000/µL or Hb increase ≥ 1 g/dL
< 40 000/µl ili povećanje Hb ≥ 1 g/dl i povećanje Hb < 1 g/dl ciljni Hb
Phlebotomy may be performed if excessively high haemoglobin levels occur.
U slučaju pojave izrazito visokih razina hemoglobina, može se učiniti flebotomija.
INFORMATION IN BRAILLE Epoetin alfa HEXAL 40,000 IU/1 mL
Epoetin alfa HEXAL 40 000 IU/1 ml
Breast-feeding
Paediatric
How to use Epoetin alfa HEXAL
Kako primjenjivati Epoetin alfa HEXAL
INFORMATION IN BRAILLE Epoetin alfa HEXAL 20,000 IU/0.5 mL
Epoetin alfa HEXAL 20 000 IU/0,5 ml
Pure red cell aplasia3, Thrombocythaemia
Poremećaji krvi i limfnog sustava izolirana aplazija crvene krvne loze3, trombocitemija rijetko
INFORMATION IN BRAILLE Epoetin alfa HEXAL 8,000 IU/0.8 mL 17.
Epoetin alfa HEXAL 8000 IU/0,8 ml
1 pre-filled syringe of 0.75 mL 6 pre-filled syringes of 0.75 mL 1 pre-filled syringe of 0.75 mL with a needle safety guard 4 pre-filled syringes of 0.75 mL with a needle safety guard 6 pre-filled syringes of 0.75 mL with a needle safety guard
1 napunjena štrcaljka od 0,75 ml sa zaštitnim mehanizmom za iglu 4 napunjene štrcaljke od 0,75 ml sa zaštitnim mehanizmom za iglu 6 napunjenih štrcaljki od 0,75 ml sa zaštitnim mehanizmom za iglu
The median TTP based on IRC-determined PD was 8.0 months in the epoetin alfa plus SOC group and 8.3 months in the SOC group (HR 1.033, 95% CI:
Medijan vremena do progresije temeljen na neovisnoj središnjoj radiološkoj ocjeni progresivne bolesti bio je 8,0 mjeseci u skupini liječenoj epoetinom alfa plus standardna terapija i 8,3 mjeseca u skupini liječenoj standardnom terapijom (HR 1,033, 95 % CI: 0,924, 1,156)
Epoetin alfa HEXAL is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
Epoetin alfa HEXAL se primjenjuje za liječenje simptomatske anemije prouzročene bolešću bubrega:
The initial dose is 150 IU/kg subcutaneously, 3 times per week.
Početna doza je 150 IU/kg, supkutano, 3 puta tjedno.
Only take one dose of Epoetin alfa HEXAL from each syringe.
Iz jedne štrcaljke uzmite samo jednu dozu lijeka Epoetin alfa HEXAL.
INFORMATION IN BRAILLE Epoetin alfa HEXAL 30,000 IU/0.75 mL 17.
Epoetin alfa HEXAL 30 000 IU/0,75 ml
Instructions on how to inject Epoetin alfa HEXAL yourself at the end of the leaflet.
Upute za samostalnu primjenu injekcije Epoetin alfa HEXAL na kraju ove upute.
The starting dose is 50 IU/kg intravenously, 3 times per week.
Faza korekcije Početna doza je 50 IU/kg intravenski, 3 puta tjedno.