natgillin/translations-raw huggingface dataset:
These antibodies have been shown to cross-react with all ESAs, and patients suspected or confirmed to have antibodies to erythropoietin should not be switched to MIRCERA.
Bolniki, pri katerih obstaja sum ali je potrjeno, da imajo protitelesa proti eritropoetinu, naj ne bi prešli na zdravilo MIRCERA.
Haemoglobin concentration:
Koncentracija hemoglobina:
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12g/ dl (7.5 mmol/ l).
Pri bolnikih s kronično ledvično odpovedjo vzdrževana koncentracija hemoglobina ne sme preseči zgornje meje ciljne koncentracije hemoglobina, priporočene v poglavju 4. 2.
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
V kliničnih preskušanjih so opazili povečano tveganje za smrt in resne srčno- žilne dogodke, če je bila ciljna koncentracija hemoglobina, dosežena z zdravili za stimulacijo eritropoeze, nad 12 g/ dl (7, 5 mmol/ l).
4 Blood pressure monitoring:
4 Kontrolirana klinična preskušanja niso pokazala pomembnih koristi, ki bi jih pripisali dajanju epoetinov, če so koncentracije hemoglobina povečane nad raven, ki je potrebna za kontrolo simptomov anemije in izognitev transfuzijam krvi.
As with other ESAs, blood pressure may rise during treatment with MIRCERA.
Kot pri drugih zdravilih za stimulacijo eritropoeze se lahko krvni tlak zviša tudi med zdravljenjem z zdravilom MIRCERA.
If high blood pressure is difficult to control by medical treatment or dietary measures, the dose must be reduced or administration discontinued (see section 4.2).
Če je krvni tlak težko obvladovati z zdravljenjem ali dieto, odmerek znižamo ali dajanje zdravila prekinemo (glejte poglavje 4. 2).
Effect on tumour growth:
Vpliv na rast tumorja:
MIRCERA, like other ESAs, is a growth factor that primarily stimulates red blood cell production.
Tudi MIRCERA je kot druga zdravila, ki spodbujajo eritropoezo, rastni dejavnik, ki primarno spodbuja nastajanje rdečih krvnih celic.
MIRCERA is not approved for the treatment of anaemia in patients with cancer.
Zdravilo MIRCERA ni odobreno za zdravljenje anemije pri bolnikih z rakom.
The safety and efficacy of MIRCERA therapy has not been established in patients with haemoglobinopathies, seizures, bleeding or a recent history of bleeding requiring transfusions or with platelet levels greater than 500 x 109/ l.
Varnosti in učinkovitosti zdravljenja z zdravilom MIRCERA niso raziskali pri bolnikih s hemoglobinopatijami, epileptičnimi napadi, krvavitvami ali nedavno krvavitvijo, ki je zahtevala transfuzijo, ter pri koncentracijah trombocitov, večjih od 500 x 109/ l.
Pregnancy:
Nosečnost Ni podatkov o uporabi zdravila MIRCERA pri nosečnicah.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development but indicate a class-related reversible reduction in foetal weight (see section 5.3).
Študije na živalih niso pokazale neposrednih škodljivih vplivov na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj; reverzibilno zmanjšanje plodove teže (glejte poglavje 5. 3) pa nakazuje povezavo s to skupino zdravil.
It is unknown whether methoxy polyethylene glycol-epoetin beta is excreted in human breast milk.
Dojenje Ni znano, če metoksipolietilenglikol epoetin beta prehaja v materino mleko.
The safety data base from clinical trials comprised 2’ 737 CKD patients, including 1’ 789 patients treated with MIRCERA and 948 with another ESA.
Podatke o varnosti v kliničnih preskušanjih so pridobili pri 2. 737 bolnikih s kronično ledvično boleznijo; od tega jih je bilo 1. 789 zdravljenih z zdravilom MIRCERA, 948 pa z drugimi zdravili, ki spodbujajo eritropoezo.
Approximately 6% of patients treated with MIRCERA are expected to experience adverse reactions.
Neželeni učinki so se pojavili pri približno 6% bolnikov, ki so se zdravili z zdravilom MIRCERA.
The frequencies are defined as follows: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000)
5 Navedba pogostnosti neželenih učinkov: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000).
5 Table 2:
Preglednica 2.
Adverse reactions attributed to the treatment with MIRCERA in controlled clinical trials in CKD patients
Neželeni učinki, povezani z zdravljenjem z zdravilom MIRCERA v kontroliranih kliničnih preskušanjih pri bolnikih s kronično ledvično boleznijo
System organ class Nervous system disorders
Organski sistem Bolezni živčevja
Adverse reaction Headache
Pogostnost Neželeni učinek občasni glavobol
Hypertensive encephalopathy
redki hipertenzivna encefalopatija
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja Poškodbe in zastrupitve in zapleti pri posegih
Rare
redki občasni
Injury, poisoning and procedural complications
makulopapulozni izpuščaj tromboza žilnega pristopa
Hot flush
vročinski valovi
All other events attributed to MIRCERA were reported with rare frequency and the majority were mild to moderate in severity.
O vseh drugih dogodkih, pripisanih zdravilu MIRCERA, so poročali redko; večina jih je bila blagih do srednje hudih.
These events were consistent with comorbidities known in the population.
Dogodki so bili skladni z znanimi sočasnimi boleznimi v populaciji.
During treatment with MIRCERA, a slight decrease in platelet counts remaining within the normal range was observed in clinical studies.
Med zdravljenjem z zdravilom MIRCERA so v kliničnih preskušanjih opazili rahel padec števila trombocitov, ki pa je ostal v mejah normale.
Platelet counts below 100 x 109/ l were observed in 7% of patients treated with MIRCERA and 4% of patients treated with other ESAs.
Število trombocitov pod 100 x 109/ l so opazili pri 7% bolnikov, zdravljenih z zdravilom MIRCERA, in pri 4% bolnikov, ki so se zdravili z drugimi zdravili za stimulacijo eritropoeze.
Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e. g. excessive erythropoiesis.
4. 9 Preveliko odmerjanje
In case of excessive haemoglobin levels, treatment with MIRCERA should be temporarily discontinued (see section 4.2).
Kadar so koncentracije hemoglobina prevelike, je treba zdravljenje z zdravilom MIRCERA začasno prekiniti (glejte poglavje 4. 2).
Other antianemic preparations, ATC code:
Oznaka ATC:
Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin.
To se kaže s počasnejšo vezavo na receptor in hitrejšo disociacijo z receptorja, z zmanjšano specifično aktivnostjo in vitro ter s povečano aktivnostjo in vivo.
MIRCERA stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow.
Zdravilo MIRCERA spodbuja eritropoezo prek interakcije z eritropoetinskim receptorjem, ki se nahaja na progenitornih matičnih celicah v kostnem mozgu.
Data from correction studies show that the haemoglobin response rates in the MIRCERA group at the end of the correction period were high (93.3% and 97.5% in the studies in patients on dialysis and not
6 Podatki iz študij, ki so proučevale fazo korekcije, kažejo, da so bili na koncu faze korekcije deleži povečanja hemoglobina v skupini, ki je prejemala zdravilo MIRCERA, visoki (93, 3% pri dializnih bolnikih in 97, 5% pri nedializnih bolnikih) in primerljivi z deleži v primerjalni skupini (91, 3% in 96, 3%).
6 on dialysis, respectively) and comparable to comparators (91.3% and 96.3%, respectively).
Mediana časa do odgovora na zdravljenje je bila v skupini, ki je prejemala zdravilo MIRCERA, 43 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo 0, 2 g/ dl/ teden).
The median time to response was 43 days in the MIRCERA arm and 29 days in the comparator arm, with increases of haemoglobin within the first 6 weeks of 0.2 g/ dl/ week and 0.3 g/ dl/ week, respectively.
V primerjalni skupini je mediana znašala 29 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo 0, 3 g/ dl/ teden).
Four randomized controlled studies were performed in dialysis patients treated with darbepoetin alfa or epoetin at the time of enrollment.
Pri dializnih bolnikih, ki so se v času vključevanja v raziskavo zdravili z darbepoetinom alfa ali epoetinom, so opravili štiri randomizirane kontrolirane klinične raziskave.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2’ 833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Od teh petih študij so bile štiri dvojno slepe, s placebom kontrolirane, ena pa je bila odprta.
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12- 14 g/ dl.
Ciljne koncentracije hemoglobina so bile v dveh študijah > 13 g/ dl, v preostalih treh pa 12−14 g/ dl.
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.
Izida za celokupno preživetje v preskušanjih se med tistimi, ki so prejemali rekombinantni humani eritropoetin, in tistimi v kontrolni skupini, ni dalo zadovoljivo razložiti s pomočjo razlik v incidenci tromboze in povezanih zapletov.
A systematic review has also been performed involving more than 9’ 000 cancer patients participating in 57 clinical trials.
Pri več kot 9. 000 bolnikih z rakom, ki so sodelovali v 57 kliničnih preskušanjih, so sistematično pregledali podatke.
0.99, 1.18; 42 trials and 8’ 167 patients).
Meta analiza podatkov o celokupnem preživetju je podala oceno razmerja ogroženosti 1, 08 v dobro kontrolne skupine (95 -% interval zaupanja 0, 99; 1, 18; 42 preskušanj in 8. 167 bolnikov).
1.35, 2.06, 35 trials and 6’ 769 patients) was observed in patients treated with recombinant human erythropoietin.
Pri bolnikih, zdravljenih z rekombinantnim humanim eritropetinom, so opazili povečano relativno tveganje za trombembolične dogodke (relativno tveganje 1, 67; 95 -% interval zaupanja 1, 35; 2, 06; 35 preskušanj in 6. 769 bolnikov).
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Iz tega sledi, da obstajajo trdni dokazi, ki kažejo na to, da lahko zdravljenje z rekombinantnim humanim eritropoetinom bolnikom z rakom pomembno škoduje.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
V pregled podatkov je bilo namreč vključenih malo takih bolnikov.
The pharmacokinetics of methoxy polyethylene glycol-epetin beta were studied in healthy volunteers and in anaemic patients with CKD including patients on dialysis and not on dialysis.
Farmakokinetiko metoksipolietilenglikol epoetina beta so raziskali pri zdravih prostovoljcih in anemičnih bolnikih s kronično ledvično boleznijo, ki so bili na dializi ali pa ne.
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 54%.
Absolutna biološka uporabnost metoksipolietilenglikol epoetina beta je bila po subkutanem dajanju 54%.
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
Absolutna biološka uporabnost metoksipolietilenglikol epoetina beta po subkutanem dajanju je bila 62%, ugotovljeni končni razpolovni čas izločanja pri dializnih bolnikih s kronično ledvično boleznijo pa 139 ur.
Following intravenous administration to CKD patients on dialysis, the total systemic clearance was 0.494 ml/ h per kg.
7 Po intravenskem dajanju pri dializnih bolnikih s kronično ledvično boleznijo je skupni sistemski očistek znašal 0, 494 ml/ h na kg.
7 A comparison of serum concentrations of methoxy polyethylene glycol-epetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Primerjava serumskih koncentracij metoksipolietilenglikol epoetina beta, ki so jih izmerili pred hemodializo in po njej pri 41 bolnikih s kronično ledvično boleznijo, je pokazala, da hemodializa na farmakokinetiko tega zdravila ne vpliva.
In a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epetin beta are similar in patients with severe hepatic impairment as compared to healthy subjects (see section 4.2).
V študiji enkratnega odmerjanja je bila po intravenskem dajanju zdravila farmakokinetika metoksipolietilenglikol epoetina beta pri bolnikih s hudo jetrno okvaro podobna tisti pri zdravih osebah (glejte poglavje 4. 2).
The carcinogenic potential of methoxy polyethylene glycol-epetin beta has not been evaluated in long- term animal studies.
Kancerogenega potenciala metoksipolietilenglikol epoetina beta v dolgoročnih raziskavah na živalih niso ocenjevali.
In addition, using a panel of human tissues, the in vitro binding of methoxy polyethylene glycol-epetin beta was only observed in target cells (bone marrow progenitor cells).
Pri uporabi plošče s humanimi tkivi so in vitro vezavo metoksipolietilenglikol epoetina beta opazili le pri tarčnih celicah (progenitorne matične celice kostnega mozga).
No significant placental transfer of methoxy polyethylene glycol-epetin beta was observed in the rat, and studies in animals have not shown any harmful effect on pregnancy, embryofoetal development, parturition or postnatal development.
Pri podganah pomembnega prehajanja metoksipolietilenglikol epoetina beta skozi placento niso opazili.
Physical, cognitive, or sexual developments in the offspring of mothers receiving methoxy polyethylene glycol-epetin beta during gestation and lactation were not affected.
Telesni, kognitivni ali spolni razvoj potomcev samic, ki so prejemale metoksipolietilenglikol epoetin beta med gestacijo in laktacijo, ni bil prizadet.
When methoxy polyethylene glycol-epetin beta was administered subcutaneously to male and female rats prior to and during mating, reproductive performance, fertility, and sperm assessment parameters were not affected.
Ko so metoksipolietilenglikol epoetin beta dajali subkutano podganjim samcem in samicam pred parjenjem in po njem, ni bilo vpliva na ocenjevane parametre za sposobnost razmnoževanja, plodnost in seme.
Sodium dihydrogen phosphate monohydrate Sodium sulphate Mannitol (E421) Methionine Poloxamer 188 Water for injections
natrijev dihidrogenfosfat monohidrat natrijev sulfat manitol (E 421) metionin poloksamer 188 voda za injekcije
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6. 2 Inkompatibilnosti
6.4 Special precautions for storage
8 6. 4 Posebna navodila za shranjevanje
8 Keep the vial in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Končni uporabnik lahko zdravilo vzame iz hladilnika in ga hrani pri sobni temperaturi (ne nad 25 °C) za enkratno obdobje 1 meseca.
Vial (type I glass) with grey laminated stopper (bromobutyl rubber material) and flip-off cap (aluminium and polypropylene plastic material).
Viala (steklo tip I) s sivim laminiranim zamaškom (brombutilna guma) in zaporko tipa flip- off (aluminij in polipropilenski plastični material).
Pack size of 1.
V pakiranju po 1.
The sterile vial does not contain any preservative and is to be used for a single injection only.
Sterilna viala ne vsebuje konzervansov in je namenjena le za enkratno injiciranje.
Only one dose should be administered per vial.
Iz ene viale lahko odvzamemo le en odmerek.
Allow the vial to reach room temperature before injecting.
Pred injiciranjem mora viala imeti sobno temperaturo.
23 January 2009
23. januar 2009
MIRCERA 100 micrograms/ ml solution for injection
MIRCERA 100 mikrogramov/ ml raztopina za injiciranje
1 ml (one vial) contains 100 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (ena viala) vsebuje 100 mikrogramov metoksipolietilenglikol epoetina beta *.
* Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG).
* Beljakovina, pridobljena iz celične kulture jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA, kovalentno vezana na linearni metoksipolietilenglikol (PEG).
10 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
10 Bolnike je treba pozorno spremljati, da lahko simptome anemije ustrezno nadzorujemo s čim manjšim odobrenim odmerkom zdravila MIRCERA.
If the haemoglobin concentration above 10 g/ dl (6.21 mmol/ l) is reached for the individual patient, MIRCERA may be administered once-monthly using the dose equal to twice the previous once-every- two-weeks dose.
Odmerek je enak dvakratnemu, ki ga je bolnik prejel enkrat na dva tedna.
Patients currently treated with an ESA can be switched to MIRCERA administered once a month as a single intravenous or subcutaneous injection.
Bolniki, ki se trenutno zdravijo z zdravili za stimulacijo eritropoeze Bolniki, ki se trenutno zdravijo z zdravili za stimulacijo eritropoeze, lahko preidejo na zdravilo MIRCERA z odmerjanjem enkrat na mesec v eni intravenski ali subkutani injekciji.
The starting dose of methoxy polyethylene glycol- epoetin beta is based on the calculated previous weekly dose of darbepoetin alfa or epoetin at the time of substitution as described in Table 1.
Začetni odmerek metoksipolietilenglikol epoetina beta je izračunan na osnovi prejšnjega tedenskega odmerka darbepoetina alfa ali epoetina ob času zamenjave, kot je opisano v preglednici 1.
MIRCERA starting doses
Uvajalni odmerki zdravila MIRCERA Mesečni odmerek Prejšnji tedenski
Previous weekly Previous weekly
Prejšnji tedenski zdravila MIRCERA, odmerek odmerek darbepoetina dan intravensko ali epoetina, dan alfa, dan intravensko ali subkutano intravensko ali subkutano
Monthly MIRCERA
(mikrogram/ teden)
epoetin alfa epoetin
(mikrogram/ enkrat na
intravenous or
(i. e. / teden)
intravenous or intravenous or
mesec)
subcutaneous dose
< 8000
subcutaneous dose (IU/ week )< 8000 8000-16000 > 16000
8000 do 16000 > 16000
11 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
11 Ker so izkušnje z zdravljenjem pri bolnikih na peritonealni dializi omejene, je pri teh bolnikih priporočljivo redno spremljanje koncentracij hemoglobina in dosledno upoštevanje navodil za prilagajanje odmerkov.
Patients with hepatic impairment No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairmented patients (see section 5.2).
Bolniki z jetrno okvaro Pri bolnikih z jetrno okvaro začetnega odmerka ali smernic za prilagajanje odmerkov ni potrebno spreminjati (glejte poglavje 5. 2).
In patients with chronic kidney disease, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Pri bolnikih s kronično ledvično odpovedjo vzdrževana koncentracija hemoglobina ne sme preseči zgornje meje ciljne koncentracije hemoglobina, priporočene v poglavju 4. 2.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12g/ dl (7.5 mmol/ l).
12 bila ciljna koncentracija hemoglobina dosežena z zdravili za stimulacijo eritropoeze nad 12 g/ dl (7, 5 mmol/ l).
12 Blood pressure monitoring:
Kontrola krvnega tlaka:
The safety data base from clinical trials comprised 2’ 737 CKD patients, including 1’ 789 patients treated with MIRCERA and 948 with another ESA.
Podatke o varnosti v kliničnih preskušanjih so pridobili pri 2737 bolnikih s kronično ledvično boleznijo; od tega jih je bilo 1789 zdravljenih z zdravilom MIRCERA, 948 pa z drugimi zdravili, ki spodbujajo eritropoezo.
Approximately 6% of patients treated with MIRCERA are expected to experience adverse reactions.
Neželeni učinki so se pojavili pri približno 6% bolnikov, ki so se zdravili z
13 Table 2:
13 zdravilom MIRCERA.
Adverse reactions attributed to the treatment with MIRCERA in controlled clinical trials in CKD patients
Navedba pogostnosti neželenih učinkov: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000).
System organ class Nervous system disorders
Preglednica 2.
Frequency Uncommon
Organski sistem Bolezni živčevja
In responding to hypoxia, the natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production.
V 14 odgovoru na hipoksijo pride do interakcije med naravnim hormonom eritropoetinom in progenitornimi matičnimi celicami za eritrocite, kar poveča tvorbo rdečih krvnih celic.
Data from correction studies show that the haemoglobin response rates in the MIRCERA group at the end of the correction period were high (93.3% and 97.5% in the studies in patients on dialysis and not
Podatki iz študij, ki so proučevale fazo korekcije, kažejo, da so bili na koncu faze korekcije deleži povečanja hemoglobina v skupini, ki je prejemala zdravilo MIRCERA visoki (93, 3% pri dializnih bolnikih in 97, 5% pri nedializnih bolnikih) in primerljivi z deleži v primerjalni skupini (91, 3% in 96, 3%).
14 on dialysis, respectively) and comparable to comparators (91.3% and 96.3%, respectively).
Mediana časa do odgovora na zdravljenje je bila v skupini, ki je prejemala zdravilo MIRCERA, 43 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo 0, 2 g/ dl/ teden).
Four randomized controlled studies were performed in dialysis patients treated with darbepoetin alfa or epoetinat the time of enrollment.
Pri dializnih bolnikih, ki so se v času vključevanja v raziskavo zdravili z darbepoetinom alfa ali epoetinom, so opravili štiri randomizirane kontrolirane klinične raziskave.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2’ 833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Od teh petih študij so bile štiri dvojno slepe, s placebom primerjane, ena pa je bila odprta.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
V štirih, s placebom primerjanih študijah je bil razpon razmerja ogroženosti za celokupno preživetje med 1, 25 in 2, 47 v korist kontrolne skupine.
A systematic review has also been performed involving more than 9’ 000 cancer patients participating in 57 clinical trials.
Pri več kot 9000 bolnikih z rakom, ki so sodelovali v 57 kliničnih preskušanjih, so sistematično pregledali podatke.
0.99, 1.18; 42 trials and 8’ 167 patients).
Meta analiza podatkov o celokupnem preživetju je podala oceno razmerja ogroženosti 1, 08 v dobro kontrolne skupine (95 -% interval zaupanja 0, 99; 1, 18; 42 preskušanj in 8167 bolnikov).