natgillin/translations-raw huggingface dataset:
Do not use the pre-filled syringe if it has been dropped on a hard surface.
Ne upotrebljavajte napunjenu brizgalicu ako je pala na tvrdu površinu.
Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Liječenje simptomatske anemije u odraslih osoba koje boluju od nemijeloične maligne bolesti i primaju kemoterapiju.
Patients with solid tumours (e.g., lung, breast, colon, ovarian cancers) and lymphoid malignancies
Bolesnici sa solidnim tumorima (npr. rak pluća, dojke, kolona, jajnika) i limfoidnim malignomima (npr. limfom, multipli mijelom) bili su uključeni u klinička ispitivanja.
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.
Pomoćne tvari: natrijev dihidrogenfosfat, natrijev hidrogenfosfat, natrijev klorid, polisorbat 80 i voda za injekcije.
- The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.
- Pomoćne tvari su natrijev dihidrogenfosfat, natrijev hidrogenfosfat, natrijev klorid, polisorbat 80 i voda za injekcije.
Rotate the injection sites to avoid discomfort at the site of injection.
Treba mijenjati mjesto injiciranja kako bi se izbjegla neugoda na mjestu primjene.
Marketing Authorisation Holder and Manufacturer Amgen Europe B.V.
Nositelj odobrenja za stavljanje u promet gotovog lijeka i proizvođač Amgen Europe B.V.
In the once every three weeks group, 72% of patients required dose reductions.
U skupini koja je dobivala Aranesp jednom u 3 tjedna kod 72% bolesnika bilo je potrebno smanjiti dozu.
In a randomised, double-blind, placebo-controlled phase 3 study 2,549 adult patients with anaemia receiving chemotherapy for the treatment of advanced stage non-small cell lung cancer (NSCLC), were randomised 2:1 to darbepoetin alfa or placebo and treated to a maximum Hb of 12 g/dL.
U randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze 3, 2549 odraslih bolesnika s anemijom koji su primali kemoterapiju za liječenje uznapredovalog karcinoma pluća nemalih stanica (NSCLC) randomizirano je u omjeru 2:1 za primanje darbepoetina alfa ili placeba i liječeno je do maksimalnog hemoglobina od 12 g/dl.
Keep the syringe and sharps disposal container out of sight and reach of children.
Čuvajte spremnik za odlaganje štrcaljke i oštrih predmeta izvan pogleda i dohvata djece.
Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with ESAs, including Aranesp.
Zabilježena je povezanost izolirane aplazije crvenih stanica uzrokovane neutralizirajućim antieritropoetinskim antitijelima s LSE, uključujući Aranesp.
If an elevated or rising potassium level is observed then consideration should be given to ceasing Aranesp administration until the level has been corrected.
Ako se primijeti povišena razina kalija ili njegov porast, treba uzeti u obzir prekid primjene lijeka Aranesp dok se razina kalija ne popravi.
In a randomised clinical study 114 paediatric patients aged 2 to 18 with chronic kidney disease receiving or not receiving dialysis who were anaemic (haemoglobin < 10.0 g/dL) and not being treated with an ESA were administered darbepoetin alfa weekly (n = 58) or once every two weeks (n = 56) for the correction of anaemia.
U randomiziranom kliničkom ispitivanju na 114 pedijatrijskih bolesnika u dobi od 2 do 18 godina s kroničnom bolesti bubrega, koji jesu ili nisu na dijalizi, imaju anemiju (hemoglobin < 10,0 g/dl) i nisu bili liječeni lijekovima koji stimuliraju eritropoezu, bolesnici su dobivali darbepoetin alfa jednom tjedno (n = 58) ili jednom svaka dva tjedna (n = 56) u svrhu korekcije anemije.
There have been reports, from post-marketing experience, of serious hypersensitivity reactions including anaphylactic reaction, angioedema, allergic bronchospasm, skin rash and urticaria associated with darbepoetin alfa.
Nakon stavljanja lijeka u promet, postoje izvještaji o ozbiljnim reakcijama preosjetljivosti uključujući anafilaktičku reakciju, angioedem, alergijski bronhospazam, kožni osip i urtikariju povezane s darbepoetinom alfa.
If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
Ako imate pitanja o primjeni injekcije, obratite se svojem liječniku, medicinskoj sestri ili ljekarniku za pomoć.
A rise in haemoglobin of greater than 2 g/dL (1.25 mmol/L) over a four week period should be avoided.
Mora se izbjeći porast hemoglobina za više od 2 g/dl (1,25 mmol/l) tijekom perioda od 4 tjedna.
Aranesp in a pre-filled pen is only for subcutaneous administration.
Aranesp u napunjenoj brizgalici namijenjen je isključivo supkutanoj primjeni.
Alternatively, in patients not on dialysis, an initial dose of 0.75 mcg/kg may be administered subcutaneously as a single injection once every two weeks.
Alternativno, bolesnicima koji nisu na dijalizi može se supkutano primijeniti početna doza od 0,75 μg/kg kao pojedinačna injekcija jednom svaka dva tjedna.
Median overall survival in the epoetin alfa plus SOC group was 17.8 months compared with 18.0 months in the SOC alone group (HR 1.07, 95% CI: 0.97, 1.18).
Medijan ukupnog preživljenja u skupini koja je primala epoetin alfa i standardnu zdravstvenu skrb iznosio je 17,8 mjeseci u usporedbi s 18,0 mjeseci u skupini samo sa standardnom zdravstvenom skrbi (HR 1,07; 95% CI: 0,97; 1,18).
Aranesp 40 µg injection Darbepoetin alfa IV/SC
Aranesp 40 µg injekcija darbepoetin alfa i.v./s.c.
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 bolesti (TTP, engl. time to progression) temeljen na progresivnoj bolesti (PD, engl. progressive disease) koju je utvrdio istraživač, iznosio je 7,5 mjeseci u skupini koja je primala epoetin alfa i standardnu zdravstvenu skrb i 7,5 mjeseci u skupini samo sa standardnom zdravstvenom skrbi (HR 1,099; 95% CI: 0,998; 1,210).
HR 1.05, 95% CI (0.94, 1.17)), or all-cause mortality or end stage renal disease (ESRD) (darbepoetin alfa vs placebo; HR 1.06, 95% CI (0.95, 1.19)).
Ispitivanje nije doseglo primarne ishode sniženja rizika za sve uzroke mortaliteta ili kardiovaskularnog morbiditeta (darbepoetin alfa naspram placeba; HR 1,05, 95% Cl (0,94; 1,17) niti sniženja rizika svih uzroka mortaliteta ili terminalnog stadija kroničnog zatajenja bubrega (darbepoetin alfa naspram placeba; HR 1,06, 95% CI (0,95; 1,19)).
• Your healthcare provider has prescribed the Aranesp pre-filled pen for injection into the tissue just under the skin (subcutaneous use).
• Zdravstveni radnik Vam je propisao Aranesp napunjenu brizgalicu za davanje injekcije u tkivo neposredno ispod kože (supkutano).
Do not touch this area again before injecting.
Ne dirajte očišćeno mjesto prije injiciranja.
Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary.
Liječnik će redovitim pretragama krvi procjenjivati odgovor na liječenje i korigirati dozu, ako je to potrebno.
In patients ≥ 11 years of age not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Kod bolesnika u dobi od 11 godina i starijih, koji nisu na dijalizi, kad je ciljni hemoglobin dostignut s jednom primjenom svaka 2 tjedna, Aranesp se može nastaviti primjenjivati supkutano jednom mjesečno, uz početnu dozu koja je dvostruko veća od prethodne, davane jednom svaka 2 tjedna.
Solution for injection (injection) in pre-filled syringe.
Otopina za injekciju (injekcija) u napunjenoj štrcaljki.
• Sharps disposal container
• Spremnik za odlaganje oštrog otpada
The vial contains either 25, 40, 60, 100, 200 or 300 micrograms of darbepoetin alfa.
Bočica sadrži 25, 40, 60, 100, 200 ili 300 mikrograma darbepoetina alfa.
• Keep used syringes out of the reach and sight of children.
• Držite iskorištene štrcaljke izvan dohvata i pogleda djece.
Injection site pain was reported as attributable to treatment in studies where Aranesp was administered via subcutaneous injection.
Postoje izvješća o pojavi boli na mjestu injiciranja, što se može povezati s liječenjem lijekom Aranesp koji je davan supkutano.
Syringe safety guard
Sigurnosni štitnik štrcaljke
If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.
U tom slučaju, počet ćete primjenjivati Aranesp na novi način uz istu dozu koju ste prethodno primali, a liječnik će pretragama krvi nadzirati liječi li se anemija i dalje ispravno.
A Remove one pre-filled pen from the carton.
Izvadite jednu napunjenu brizgalicu iz pakiranja.
The frequency is estimated from clinical trial data as uncommon.
Učestalost je procijenjena iz podataka kliničkog ispitivanja kao manje često.
Before administration the Aranesp solution should be inspected for visible particles.
Prije primjene mora se pregledati jesu li u Aranesp otopini prisutne vidljive čestice.
How to use Aranesp
Kako primjenjivati Aranesp
In a randomised, double-blind, placebo-controlled study (TREAT) of 4,038 CRF patients not on dialysis with type 2 diabetes and haemoglobin levels ≤ 11 g/dL, patients received either treatment with darbepoetin alfa to target haemoglobin levels of 13 g/dL or placebo (with darbepoetin alfa rescue at haemoglobin less than 9 g/dL).
U randomiziranom dvostruko slijepom, placebom kontroliranom ispitivanju (TREAT) od 4038 bolesnika s kroničnim zatajenjem bubrega koji nisu na dijalizi i dijabetesom tip 2 te vrijednostima hemoglobina ≤ 11 g/dl, bolesnici su liječeni ili darbepoetinom alfa do ciljnih vrijednosti hemoglobina od 13 g/dl ili placebom (liječeni darbepoetinom alfa kod vrijednosti hemoglobina niže od 9 g/dl).
Do not leave the pre-filled pen in direct sunlight.
Ne izlažite napunjenu štrcaljku izravnoj sunčevoj svjetlosti.
The frequency is estimated from clinical trial data as uncommon in cancer patients.
Učestalost je procijenjena iz podataka kliničkih ispitivanja kao manje česta kod bolesnika s rakom.
Pharmacotherapeutic group: Anti-anaemic preparations, other anti-anaemic preparations, ATC Code: B03XA02.
Farmakoterapijska skupina: antianemici, ostali pripravci za liječenje anemije.
Do not remove the grey cap from the pre-filled pen yet.
Nemojte još skidati sivi pokrov s napunjene brizgalice.
Marketing Authorisation Holder Amgen Europe B.V.
Nositelj odobrenja za stavljanje u promet gotovog lijeka Amgen Europe B.V.
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, once your anaemia is corrected you will continue to receive Aranesp given as a single injection, either once a week or once every two weeks.
Nakon što im se korigira anemija, svi odrasli i pedijatrijski bolesnici u dobi od ≥ 1 godina s kroničnim zatajenjem bubrega nastavit će primati Aranesp kao jednu injekciju jednom tjedno ili jednom svaka dva tjedna.
Aranesp 10 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 15 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 20 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 30 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 40 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 50 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 60 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 80 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 100 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 130 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 150 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 300 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 500 micrograms solution for injection in pre-filled pen (SureClick) darbepoetin alfa
Aranesp 10 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 15 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 20 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 30 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 40 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 50 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 60 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 80 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 100 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 130 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 150 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 300 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) Aranesp 500 mikrograma otopina za injekciju u napunjenoj brizgalici (SureClick) darbepoetin alfa
Aranesp has no or negligible influence on the ability to drive and use machines.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Aranesp ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
This study supports 500 mcg once every three weeks being comparable to once weekly administration with respect to the incidence of subjects receiving at least one red blood cell transfusion from week 5 to the end of treatment phase.
S obzirom na incidenciju primanja najmanje jedne transfuzije crvenih krvnih stanica od 5. tjedna do kraja faze liječenja, ovo ispitivanje podupire usporedivost primjene doze od 500 μg jednom u 3 tjedna s primjenom jednom tjedno.
If the bone marrow is consistent with PRCA, testing for anti-erythropoietin antibodies should be performed.
Ako se pregledom koštane srži utvrdi izolirana aplazija eritrocita (PRCA), treba odrediti prisutnost antieritropoetinskih antitijela.
1 Adverse reactions identified in the post-marketing environment.
1 Nuspojave uočene nakon stavljanja lijeka u promet.
Your injection is to be given under the skin (subcutaneous), and so you may use the Aranesp pre-filled pen.
Injekciju je potrebno dati pod kožu (supkutano) i tako možete koristiti lijek Aranesp u napunjenoj brizgalici.
Potassium elevation has been reported in a few patients receiving Aranesp, though causality has not been established.
Kod nekoliko bolesnika koji su primali Aranesp zabilježen je porast kalija, premda povezanost s lijekom nije utvrđena.
Aranesp 10 micrograms solution for injection in pre-filled syringe Aranesp 15 micrograms solution for injection in pre-filled syringe Aranesp 20 micrograms solution for injection in pre-filled syringe Aranesp 30 micrograms solution for injection in pre-filled syringe Aranesp 40 micrograms solution for injection in pre-filled syringe Aranesp 50 micrograms solution for injection in pre-filled syringe Aranesp 60 micrograms solution for injection in pre-filled syringe Aranesp 80 micrograms solution for injection in pre-filled syringe Aranesp 100 micrograms solution for injection in pre-filled syringe Aranesp 130 micrograms solution for injection in pre-filled syringe Aranesp 150 micrograms solution for injection in pre-filled syringe Aranesp 300 micrograms solution for injection in pre-filled syringe Aranesp 500 micrograms solution for injection in pre-filled syringe darbepoetin alfa
Aranesp 10 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 15 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 20 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 30 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 40 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 50 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 60 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 80 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 100 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 130 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 150 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 300 mikrograma otopina za injekciju u napunjenoj štrcaljki Aranesp 500 mikrograma otopina za injekciju u napunjenoj štrcaljki darbepoetin alfa
• Hives (urticaria)
• koprivnjača (urtikarija)
Do not attempt to remove the peelable label on the pre-filled syringe barrel before administering your injection.
Ne pokušavajte odlijepiti etiketu s napunjenog spremnika štrcaljke prije primjene injekcije.
4 single use pre-filled pens
4 napunjene brizgalice za jednokratnu uporabu
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY
NALJEPNICA NAPUNJENE ŠTRCALJKE BEZ PODLOŠKA
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PODLOŽAK ZA NAPUNJENU ŠTRCALJKU
Convulsions have been reported in patients receiving darbepoetin alfa in post-marketing experience (see section 4.4).
Konvulzije su prijavljene kod bolesnika koji su primali darbepoetin u ispitivanjima nakon stavljanja lijeka u promet (vidjeti dio 4.4).
Adult patients with chronic renal failure
Odrasli bolesnici s kroničnim zatajenjem bubrega
Then LIFT the syringe off skin.
ODVOJITE štrcaljku od kože.
Solution for injection (injection) in vial.
Otopina za injekciju (injekcija) u bočici.
The following side effects have been experienced by some patients taking Aranesp:
Neki bolesnici koji uzimaju Aranesp iskusili su sljedeće nuspojave:
In patients not on dialysis, Aranesp may continue to be administered as a single injection once weekly or once every two weeks or once monthly.
Kod bolesnika koji nisu na dijalizi, može se nastaviti s primjenom lijeka Aranesp kao pojedinačne injekcije jednom tjedno ili jednom svaka dva tjedna ili jednom mjesečno.
Only solutions which are colourless, clear or slightly opalescent, should be injected.
Injicirati se smiju samo bezbojne, bistre ili lagano opalescentne otopine.
Allow the container to reach room temperature before injecting.
Prije injiciranja spremnik treba postići sobnu temperaturu.
• Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
• ozbiljne reakcije na koži, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, prijavljene su vezano uz liječenje epoetinom.
Data from 809 patients receiving Aranesp in European clinical studies were analysed to assess the dose required to maintain haemoglobin; no difference was observed between the average weekly dose administered via the intravenous or subcutaneous routes of injection.
Analizirani su podaci iz kliničkih ispitivanja provedenih u Europi na 809 bolesnika koji su primali Aranesp da bi se procijenila doza potrebna za održavanje hemoglobina.
Aranesp is available in packs of 1 or 4 vials.
Aranesp je dostupan u pakovanjima od 1 ili 4 bočice.
Do not use the pre-filled pen if the medicine is cloudy or discoloured or contains flakes or particles.
Ne upotrebljavajte napunjenu brizgalicu ako lijek izgleda mutan ili je promijenio boju ili ako su u njemu vidljive pahuljice ili čestice.
Do not reuse the pre-filled pen.
Nemojte ponovno upotrebljavati iskorištenu brizgalicu.
Paediatric population with chronic renal failure
Pedijatrijska populacija s kroničnim zatajenjem bubrega
Do not use the pre-filled pen after the expiry date on the label.
Ne upotrebljavajte napunjenu brizgalicu nakon isteka roka valjanosti navedenog na naljepnici.
In an European observational registry study which enrolled 319 paediatric patients with chronic kidney disease (13 (4.1%) patients < 1 year of age, 83 (26.0%) patients 1-< 6 years of age, 90 (28.2%) patients 6-< 12 years of age, and 133 (41.7%) patients ≥ 12 years of age) receiving darbepoetin alfa, mean haemoglobin concentrations ranging between 11.3 and 11.5 g/dL and mean weight-adjusted darbepoetin alfa doses remained relatively constant (between 2.31 mcg/kg month and 2.67 mcg/kg month) over the study period for the entire study population.
U jednom ispitivanju iz europskog opservacijskog registra u koje je bilo uključeno 319 pedijatrijskih bolesnika s kroničnom bubrežnom bolesti (13 (4,1%) bolesnika u dobi < 1 godine, 83 (26,0%) bolesnika u dobi od 1 < 6 godina, 90 (28,2%) bolesnika u dobi od 6 < 12 godina i 133 (41,7%) bolesnika u dobi
The clinical results obtained so far do not indicate any interaction of darbepoetin alfa with other substances.
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Dosadašnji rezultati kliničkih ispitivanja nisu pokazali nikakve interakcije darbepoetina alfa s drugim tvarima.
1 single use pre-filled syringe with automatic needle guard.
1 napunjena štrcaljka s automatskim štitnikom za iglu za jednokratnu uporabu.
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, Aranesp is given as a single injection, either under your skin (subcutaneous) or into a vein (intravenous).
Svim odraslim i pedijatrijskim bolesnicima u dobi od 1 godine i starijima s kroničnim zatajenjem bubrega, Aranesp se daje kao jedna injekcija, potkožno (supkutano) ili u venu (intravenski).
Do not remove the cap from the syringe until you are ready to inject.
Ne uklanjajte poklopac sa štrcaljke prije nego što ste spremni za injiciranje.
Dialysis patients converting from once weekly to once every other week dosing with Aranesp should initially receive a dose equivalent to twice the previous once weekly dose.
Bolesnici na dijalizi koji prelaze s doziranja lijekom Aranesp jednom tjedno na svaka 2 tjedna trebaju početno primati dozu koja je dvostruko veća od prethodne doze jednom tjedno.
• shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dL (8.7 mmol/L), ESAs are not indicated for use in this patient population.
• skraćenje vremena do napredovanja tumora u bolesnika s uznapredovalim rakom glave i vrata koji primaju radioterapiju kod primjene radi ciljne koncentracije hemoglobina veće od 14 g/dl (8,7 mmol/l).
Immune system disorders
Poremećaji imunološkog sustava Vrlo često
In dialysis patients, Aranesp may continue to be administered as a single injection once weekly or once every two weeks.
U bolesnika na dijalizi može se nastaviti s primjenom lijeka Aranesp kao pojedinačne injekcije jednom tjedno ili jednom svaka 2 tjedna.
The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex).
Pokrov igle napunjene brizgalice sadrži suhu prirodnu gumu (derivat lateksa).
The median TTP based on IRCdetermined 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: 0.924, 1.156).
Independent Review Committee) iznosio je 8,0 mjeseci u skupini koja je primala epoetin alfa i standardnu zdravstvenu skrb i 8,3 mjeseci u skupini samo sa standardnom zdravstvenom skrbi (HR 1,033; 95% CI: 0,924; 1,156).
• Once your pre-filled pen has been removed from the refrigerator, and left at room temperature (up to 25ºC) for approximately 30 minutes before injection, it must either be used within seven days or disposed of.
• Nakon što izvadite brizgalicu iz hladnjaka i ostavite je na sobnoj temperaturi (do 25ºC) oko 30 minuta prije injiciranja, brizgalicu je potrebno iskoristiti unutar sedam dana ili baciti.
4 single use pre-filled syringes with automatic needle guards.
4 napunjene štrcaljke s automatskim štitnikom za iglu za jednokratnu uporabu.
Subject incidence
Incidencija kod ispitanika
Characteristics (Revision 2, September 2009), frequency of adverse reactions identified in the post-marketing setting was determined using the “Rule of three”.
(revizija 2, rujan 2009.), učestalost nuspojava uočenih nakon stavljanja lijeka u promet određena je primjenom
If the increase in haemoglobin is inadequate (less than 1 g/dL (0.6 mmol/L) in four weeks) increase the dose by approximately 25%.
Ako je povećanje hemoglobina nedovoljno (manje od 1 g/dl (0,6 mmol/l) u četiri tjedna), povećajte dozu za otprilike 25%.