natgillin/translations-raw huggingface dataset:
Very common: Embolism** Common: Thrombosis*** Not known: Cerebrovascular accident, haemorrhage, superior sagittal sinus thrombosis *Adverse reactions observed with other asparaginases in the class **Cases of pulmonary embolism, venous thrombosis, venous thrombosis limb, and thrombophlebitis superficial were observed in DFCI 11-001 ***Legend: CNS thrombosis 
*Neželeni učinki, ugotovljeni pri drugih asparaginazah v istem razredu **Primere pljučne embolije, venske tromboze, venske tromboze v okončini in površinskega tromboflebitisa so ugotovili v študiji DFCI 11-001 ***Legenda: tromboza CŽS
Hypersensitivity reactions to Oncaspar, including life-threatening anaphylaxis, angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnoea, pruritus and rash, can occur during therapy (see sections 4.3 and 4.4). 
Med zdravljenjem se lahko pojavijo preobčutljivostne reakcije na zdravilo Oncaspar, vključno z življenjsko nevarno anafilaksijo, angioedemom, otekanjem ustnic, otekanjem oči, eritemom, znižanim krvnim tlakom, bronhospazmom, dispnejo, pruritusom in izpuščajem (glejte poglavji 4.3 in 4.4).
Disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sucrose, and sodium hydroxide and hydrochloric acid (for pH adjustment). 
Natrijev fosfat heptahidrat, natrijev dihidrogenfosfat monohidrat, natrijev klorid, saharoza ter natrijev hidroksid in klorovodikova kislina (za uravnavanje pH).
ALL patients with several relapses were treated either with Oncaspar or with native asparaginase from E. coli as part of an induction therapy. 
Z zdravilom Oncaspar ali z nativno asparaginazo iz E. coli so v okviru indukcijske terapije zdravili bolnike z ALL z več recidivi.
Further detailed information can be found in the SmPC. 
Podrobnejše informacije lahko najdete v povzetku glavnih značilnosti zdravila.
The recommended dose in patients with a body surface area (BSA) ≥0.6 m2 and who are ≤21 years of age is 2,500 U of pegaspargase (equivalent to 3.3 ml Oncaspar)/m2 body surface area every 14 days. 
≤ 21 let je 2.500 e. pegaspargaze (ustreza 3,3 ml zdravila Oncaspar)/m² telesne površine vsakih 14 dni.
A dose-independent rise in serum transaminases, and serum bilirubin is commonly observed. 
Pogosta so zvišanja ravni transaminaz v serumu in zvišanja ravni bilirubina v serumu, ki so neodvisna od odmerka.
For intravenous administration, the reconstituted solution should be diluted in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution. 
Pri intravenskem dajanju je treba rekonstituirano raztopino razredčiti v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9-%) za injiciranje ali 5% raztopini glukoze.
Each pack contains 1 glass vial with 3,750 U pegaspargase. 
Eno pakiranje vsebuje 1 stekleno vialo s 3.750 e. pegaspargaze.
In Study AALL07P4, PK parameters after a single 2,500 U/m2 IV dose during Induction were calculated by noncompartmental PK analysis from sequential plasma samples and are depicted in Table 3 (see section 5.1). 
V študiji AALL07P4 so bili v analizi farmakokinetike na osnovi zaporednih vzorcev plazme brez upoštevanja kompartmentov izračunani parametri farmakokinetike po enkratnem odmerku 2.500 e./m2
Hypersensitivity reactions to pegaspargase, including life-threatening anaphylaxis, can occur during therapy, including in patients with known hypersensitivity to E. coli derived asparaginase formulations. 
Med zdravljenjem, vključno pri bolnikih z znano preobčutljivostjo za formulacije z asparaginazo iz E. coli, se lahko pojavijo preobčutljivostne reakcije na pegaspargazo, vključno z življenjsko nevarno anafilaksijo.
PK Parameters 
Farmakokinetični parametri
The percentage of patients in the Oncaspar arm with evaluable Low End-Induction MRD (<0.001 detectable disease) at Day 32 was 87.9% (80/91). 
Odstotek bolnikov v skupini z zdravilom Oncaspar z negativnim statusom ocenjene minimalne rezidualne bolezni (MRD - Minimal Residual Disease) (< 0,1 % levkemičnih celic v kostnem mozgu) na 29. dan indukcije je bil 80 % (40/50).
The other ingredients are: disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) (see section 2 “Oncaspar contains sodium”). 
Pomožne snovi so: dinatrijev fosfat heptahidrat, natrijev dihidrogenfosfat monohidrat, natrijev klorid in saharoza, natrijev hidroksid (za uravnavanje pH), klorovodikova kislina (za uravnavanje pH) (glejte poglavje 2 Zdravilo Oncaspar vsebuje natrij).
The diluted solution can be given together with an already-running infusion of either sodium chloride 9 mg/ml or 5% glucose. 
Razredčena raztopina se lahko daje skupaj z infuzijo, ki je že v uporabi, bodisi z natrijevim kloridom 9 mg/ml ali s 5-% glukozo.
What Oncaspar contains 
Kaj vsebuje zdravilo Oncaspar
A temporary suppression in body weight gains and a temporary reduction in total leukocyte counts were observed in dogs which were treated with pegaspargase 1200 U/kg weekly for 2 weeks. 
Pri psih, ki so prejemali pegaspargazo 1.200 e./kg enkrat tedensko 2 tedna, so ugotovili začasno supresijo prirasta telesne mase in začasno znižanje skupnega števila levkocitov.
One ml of solution contains 750 units pegaspargase . 
En ml raztopine vsebuje 750 enot pegaspargaze.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous or intramuscular use. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA za intravensko ali intramuskularno uporabo Pred uporabo preberite priloženo navodilo!
Reproductive toxicity No studies of reproductive toxicity were conducted with pegaspargase. 
Škodljivi učinki na sposobnost razmnoževanja Študije škodljivih učinkov pegaspargaze na sposobnost razmnoževanja niso bile opravljene.
First-Line (ALL patients non-hypersensitive to native E. coli L-asparaginase) The safety and efficacy of Oncaspar was evaluated in an open-label, multicentre, randomised, active-controlled study (StudyCCG-1962). 
Varnost in učinkovitost zdravila Oncaspar so ocenili v odprti, multicentrični, randomizirani, aktivno kontrolirani študiji (študija CCG-1962).
In Study DFCI 11-001, assessments of asparaginase activity were performed following a single IV dose of Oncaspar 2,500 U/m2 BSA during Induction, and every two weeks during post-Induction (see section 5.1). 
odmerku zdravila Oncaspar 2.500 e./m2 BSA med indukcijo in vsaka dva tedna po indukciji (glejte poglavje 5.1).
If pancreatitis is suspected, Oncaspar should be discontinued; if pancreatitis is confirmed, Oncaspar should not be restarted. 
Če obstaja sum na pankreatitis, moramo uporabo zdravila Oncaspar prekiniti.
What Oncaspar looks like and contents of the pack Oncaspar is a white to off-white powder. 
Zdravilo Oncaspar je bel do umazano bel prašek.
How to store Oncaspar 
Shranjevanje zdravila Oncaspar
* N=47 evaluable subjects. 
*n = 47 ocenljivih oseb † Mediana (10., 90. percentil)
Since the proteolytic enzymes responsible for Oncaspar metabolism are ubiquitously distributed in tissues the exact role of the liver is unknown: however any decrease in liver function is not expected to present clinical relevant problems in the use of Oncaspar. 
natančna vloga jeter ni znana, vendar se ne pričakuje, da zmanjšanje delovanja jeter predstavlja klinično pomembno težavo pri uporabi zdravila Oncaspar.
Inflammation of the pancreas, that in some cases caused death, can occur with Oncaspar treatment. 
Pri zdravljenju z zdravilom Oncaspar se lahko pojavi vnetje trebušne slinavke, ki je v nekaterih primerih smrtno.
Talk to your doctor before you are given Oncaspar. 
Preden boste prejeli zdravilo Oncaspar, se posvetujte z zdravnikom.
Oncaspar was given IM in a dose of 2,500 U/m² BSA on days 1 and 15 of induction. 
v odmerku 2.500 e./m² BSA, intramuskularno na 1. in 15. dan indukcije.
Adverse reactions were loss of body weight, piloerection and reduced activity. 
piloerekcija in zmanjšana aktivnost.
The diluted solution can be given over 1 to 2 hours together with an already-running infusion of either sodium chloride 9 mg/ml or 5% glucose. 
Razredčena raztopina se lahko daje v obdobju od 1 do 2 ur, skupaj z infuzijo, ki je že v uporabi, bodisi z natrijevim kloridom 9 mg/ml ali s 5-% glukozo.
ALL patients hypersensitive to native E. coli L-asparaginase Six open-label studies evaluated Oncaspar in relapse/refractory haematological diseases. 
Šest odprtih študij je vrednotilo zdravilo Oncaspar pri recidivnih/neodzivnih hematoloških boleznih.
Cases of accidental overdose have been reported with Oncaspar. 
4.9 Preveliko odmerjanje Poročali so o primerih nenamernega prevelikega odmerjanja zdravila Oncaspar.
Ask the pharmacist how to dispose of unused medicines. 
O načinu odstranjevanja zdravila, ki ga ne uporabljate več,
Oncaspar 750 U/ml solution for injection/infusion pegaspargase 
Oncaspar 750 e./ml raztopina za injiciranje/infundiranje pegaspargaza
What you need to know before you are given Oncaspar 
Kaj morate vedeti, preden boste uporabili zdravilo Oncaspar Ne uporabljajte zdravila Oncaspar:
Do not use if the reconstituted solution is cloudy or if a precipitate has formed. 
Zdravila ne uporabljajte, če rekonstituirana raztopina postane motna ali če nastane oborina.
The diluted solution can be given over 1 to 2 hours together with an already-running infusion of either sodium chloride 9 mg/ml (0.9%) solution or 5% glucose. 
Razredčena raztopina se lahko daje v obdobju 1 do 2 ur, skupaj z infuzijo, ki je že v uporabi, bodisi z raztopino natrijevega klorida 9 mg/ml (0,9-%) ali s 5-% glukozo.
Oncaspar efficacy and safety were evaluated on the basis of three clinical studies using Oncaspar solution for injection/infusion in the first line treatment of ALL: Study CCG-1962 in standard risk 
Klinična učinkovitost in varnost Varnost in učinkovitost zdravila Oncaspar so ocenjevali na podlagi treh kliničnih študij z zdravilom
Not known (frequency cannot be estimated from the available data) - Decreased number of white blood cells and platelets; - Palpitations; - Cysts in your pancreas, swelling of the salivary glands; - High levels of urea in your blood; antibodies against Oncaspar; high levels of ammonia in your blood; decreased blood sugar levels; - Sleepiness, confusion, mild twitching of the fingers. 
- zmanjšano število belih krvnih celic in trombocitov, - palpitacije, - ciste v trebušni slinavki, otekanje žlez slinavk, - visoka raven sečnine v krvi, protitelesa proti zdravilu Oncaspar,visoka raven amoniaka v krvi,
The pharmacodynamic (PD) effect of Oncaspar was assessed after IM (Study CCG-1962) and IV administration (AALL07P4). 
V oceni populacijske farmakokinetike zdravila Oncaspar na podlagi podatkov, pridobljenih iz študij AALL07P4 (i.v.
Effective non-oral method of contraception must be used during Oncaspar treatment and for at least 6 months after Oncaspar discontinuation. 
Kontracepcija Med zdravljenjem z zdravilom Oncaspar in še najmanj 6 mesecev po prekinitvi zdravljenja z zdravilom Oncaspar je treba uporabljati učinkovito neperoralno metodo kontracepcije.
Disodium phosphate heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride 
6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat monohidrat dinatrijev fosfat heptahidrat natrijev klorid voda za injekcije
Very common (may affect more than 1 in 10 people) - Inflammation or other disorders of the pancreas (pancreatitis) causing severe stomach pain which may spread to your back, vomiting, increase in blood sugar levels; - Serious allergic reactions with symptoms such as rash, itching, swelling, hives, shortness of breath, fast heart beat and drop in blood pressure; - Severe infection with very high fever; - Blood clots. 
Nemudoma se posvetujte z zdravnikom, če se pri vas pojavi kateri od naslednjih neželenih učinkov: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - vnetje ali druge motnje trebušne slinavke (pankreatitis), ki povzročijo hude trebušne bolečine, ki se lahko razširijo v hrbet, bruhanje, zvišanje ravni sladkorja v krvi;
In Study AALL07P4, the PD effect of Oncaspar was assessed in 47 evaluable subjects with high risk B-precursor ALL who received IV doses of Oncaspar 2,500 U/m2 BSA during the Induction and 
V študiji AALL07P4 so farmakodinamični učinek zdravila Oncaspar ocenili pri 47 ocenljivih osebah z
Event-Free Survival (EFS) for the Oncaspar and native E. coli L-asparaginase arms are summarised in Table 2, Study CCG-1962 was not designed to evaluate differences in EFS rates. 
Študija CCG-1962 ni bila zasnovana za ocenjevanje razlik v deležu EFS.
Only very high doses of pegaspargase given to mice intraperitoneally as a single dose (25,000100,000 U/kg body weight) caused the death of 14% of all treated mice. 
Le zelo visoki odmerki pegaspargaze, dani mišim intraperitonealno v enkratnem odmerku (25.000
The following adverse reactions have been observed in association with asparaginase therapy. 
Opis izbranih neželenih učinkov V povezavi z zdravljenjem z asparaginazo so opazili naslednje neželene učinke.
Oncaspar native E. coli L-asparaginase 
Nativna L-asparaginaza iz E coli Oncaspar
Musculoskeletal and connective tissue disorders Common: Pain in extremities 
Bolezni kože in podkožja Zelo pogosti: izpuščaj Žilne bolezni
Oncaspar 750 U/ml powder for solution for injection/infusion pegaspargase 
Oncaspar 750 e./ml prašek za raztopino za injiciranje/infundiranje pegaspargaza
Common (may affect up to 1 in 10 people) - Severe bleeding or bruising; - Violent shaking (seizures) and loss of consciousness; - Problems with your liver (e.g., change in color of your skin or urine or stool and laboratory results of elevated liver enzymes or bilirubin). 
- težave z jetri (npr. spremenjena barva kože ali urina ali blata in rezultati laboratorijskih preiskav, ki kažejo na zvišano raven jetrnih encimov ali bilirubina).
flushing or swelling of the airways, because major allergic reactions to Oncaspar can occur. 
- če ste imeli hude alergijske reakcije na druge oblike asparaginaze, npr. srbenje, vročinske oblive in otekanje dihalnih poti, ker lahko pride do hujših alergijskih reakcij na zdravilo Oncaspar;
Method of administration Oncaspar can be given by intramuscular (IM) injection or intravenous (IV) infusion. 
Zdravilo Oncaspar se lahko daje z intramuskularno (i.m.)
Acute renal failure may develop in rare cases during treatment with L-asparaginase-containing regimens. 
Med zdravljenjem s shemami, ki vsebujejo L-asparaginazo, se lahko v redkih primerih razvije akutna ledvična odpoved.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Oncaspar 750 U/ml powder for solution for injection/infusion. 
IME ZDRAVILA IN POT(I) UPORABE Oncaspar 750 e./ml prašek za raztopino za injiciranje/infundiranje.
Serum amylase can rise during and also after the conclusion of Oncaspar therapy. 
Med zdravljenjem z zdravilom Oncaspar in po njegovem zaključku se lahko zviša raven amilaze v serumu.
For smaller volumes, the preferred route of administration is intramuscular. 
Pri manjših količinah je priporočeno intramuskularno dajanje.
After dilution, the solution should be used immediately. 
Raztopino je treba uporabiti takoj po redčenju.
Each vial contains 3,750 U of pegaspargase. 
Ena viala vsebuje 3.750 enot pegaspargaze.
In view of the unpredictability of adverse reactions, Oncaspar should be administered only by health care personnel experienced in the use of cancer chemotherapeutic medicinal products. 
Zaradi nepredvidljivosti neželenih učinkov lahko zdravilo Oncaspar dajejo le zdravstveni delavci,
Table 3: Pharmacokinetic Parameters After a Single IV Dose of Oncaspar 2,500 U/m2 BSA 
odmerke zdravila Oncaspar 2.500 e./m2 BSA.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Oncaspar 750 U/ml solution for injection/infusion. 
IME ZDRAVILA IN POT(I) UPORABE Oncaspar 750 e./ml raztopina za injiciranje/infundiranje.
Very common (may affect more than 1 in 10 people) - Changes in the function of the pancreas; - Weight loss; - Leg pain (which could be a symptom of thrombosis), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs, called pulmonary embolism); - Loss of appetite, general weakness, vomiting, diarrhoea, nausea; - Increased blood sugar levels. 
- bolečina v nogah (ki je lahko simptom tromboze), bolečina v prsih ali zasoplost (ki sta lahko simptoma krvnih strdkov v pljučih, kar imenujemo pljučna embolija),
Particularly in patients with known hypersensitivity to the other forms of L-asparaginase, hypersensitivity reactions to Oncaspar can occur during the therapy, e.g., anaphylaxis. 
zlasti pri bolnikih z znano preobčutljivostjo na druge oblike L-asparaginaze.
Unless otherwise prescribed, the recommended posology in adults aged >21 years is 2,000 U of pegaspargase (equivalent to 2.67 ml Oncaspar)/m2 body surface area every 14 days. 
pegaspargaze (ustreza 2,67 ml zdravila Oncaspar)/m2 telesne površine vsakih 14 dni.
Table 2: Event-free survival rate at 3, 5 and 7 years (Study CCG-1962) Oncaspar native E. coli L-asparaginase 
V Preglednici 2 je povzeto preživetje brez dogodkov (EFS - event-free survival) v skupini, ki je prejemala zdravilo Oncaspar, in skupini, ki je prejemala nativno L-asparaginazo iz E. coli.
The type of adverse reactions of Oncaspar is similar with that of native non-pegylated L-asparaginase (e.g., native E. coli asparaginase). 
Zdravljenje prve izbire (bolniki z ALL brez preobčutljivosti za nativno L-asparaginazo iz E. coli)
If you get any side effects you think might be related to your chemotherapy , talk to your doctor. 
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom.
Very common: Rash 
Zelo pogosti: embolija**
Common (may affect up to 1 in 10 people) - Decreased number of red blood cells; - Build-up of fluid in the stomach (ascites); - Fever and flu-like symptoms; - Mouth sores; - Back, joint or abdominal pain; - High levels of fat and cholesterol in your blood; low potassium in your blood. 
- bolečine v hrbtu, sklepih ali trebuhu, - visoka raven maščobe in holesterola v krvi, nizka raven kalija v krvi.
Do not use if the solution is cloudy or a precipitate has formed. 
Zdravila ne uporabljajte, če raztopina postane motna ali če nastane oborina.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 3,750 U of pegaspargase After reconstitution, 1 ml of solution contains 750 U of pegaspargase (750 U/ml). 
Po rekonstituciji 1 ml raztopine vsebuje 750 enot pegaspargaze (750 e./ml).
Other medicines and Oncaspar Tell your doctor if you are using, have recently used or might use any other medicines This is important as Oncaspar may increase the side effects of other medicines through its effect on the liver which plays an important role in removing medicines from the body. 
Zaradi tega zdravila ste lahko bolj dovzetni za okužbe; - če ste imeli slabo delovanje jeter ali uporabljate druga zdravila, ki lahko poškodujejo jetra; Če zdravilo Oncaspar uporabljamo v kombinaciji z drugimi načini zdravljenja raka, se lahko pojavijo poškodbe jeter in centralnega živčnega sistema; - če imate bolečine v trebuhu.
Oncaspar may cause central nervous system dysfunctions manifesting as convulsions, and less frequently confusional state and somnolence (mildly impaired consciousness). 
redkeje pa kot stanje zmedenosti in somnolenca (blago oslabljena zavest).
international normalised ratio increased, hypokalaemia, blood cholesterol increased, hypofibrinogenaemia, gamma-glutamyl transferase increased Not known: Blood urea increased, anti-pegaspargase antibodies, neutrophil count decreased, platelet count decreased, hyperammonaemia 
Zelo pogosti: zmanjšana telesna masa, hipoalbuminemija, zvišana raven alanin aminotransferaze, zvišana raven aspartat-aminotransferaze, hipertrigliceridemija, znižana raven fibrinogena v krvi, zvišana raven lipaze, zvišana raven amilaze, podaljšan aktivirani parcialni tromboplastinski čas, zvišana raven bilirubina v krvi Pogosti: podaljšan protrombinski čas, zvišano internacionalno normalizirano razmerje, hipokaliemija, zvišana raven holesterola v krvi, hipofibrinogenemija, zvišana raven gama-glutamil transferaze
NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml solution for injection/infusion pegaspargase 
IME ZDRAVILA Oncaspar 750 e./ml raztopina za injiciranje/infundiranje
History of pancreatitis, including pancreatitis related to previous L-asparaginase therapy (see section 4.4). 
Anamneza pankreatitisa, vključno s pankreatitisom v povezavi s predhodnim zdravljenjem z L
NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml powder for solution for injection/infusion pegaspargase 
IME ZDRAVILA Oncaspar 750 e./ml prašek za raztopino za injiciranje/infundiranje
When Oncaspar is used in combination with other cancer treatments, liver and central nervous system damage can occur. 
Zaradi tega zdravila ste lahko bolj dovzetni za okužbe; - če ste imeli slabo delovanje jeter ali uporabljate druga zdravila, ki lahko poškodujejo jetra; Če zdravilo Oncaspar uporabljamo v kombinaciji z drugimi načini zdravljenja raka, se lahko pojavijo poškodbe jeter in centralnega živčnega sistema;
There have been rare reports of cholestasis, icterus, hepatic cell necrosis and hepatic failure with fatal outcome. 
Poročali so o redkih primerih holestaze, ikterusa,
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) 
6.1 Seznam pomožnih snovi dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat monohidrat natrijev klorid saharoza natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
14 October 2016 EMA/656265/2016 EMEA/H/C/004003 
14. oktober 2016 EMA/656265/2016 EMEA/H/C/004003
It was to be used in patients whose disease had come back after previous treatment. 
Uporabljalo naj bi se pri bolnicah, pri katerih se je bolezen po predhodnem zdravljenju ponovno pojavila.
The company presented the results of one main study involving 456 patients with ovarian cancer that had come back 6 months or more after one previous treatment with platinum-based medicine. 
Družba je predstavila rezultate glavne študije, ki je vključevala 456 bolnic z rakom jajčnikov, ki so se vrnile šest mesecev ali več po enem predhodnem zdravljenju z zdravilom na osnovi platine.
The main measure of effectiveness was the length of time patients lived without their disease getting worse (progression-free survival). 
Glavno merilo učinkovitosti je bil čas, ki so ga bolnice preživele brez poslabšanja bolezni (preživetje brez napredovanja).
The company had not responded to the last round of questions at the time of the withdrawal. 
Družba v času umika ni odgovorila na zadnja vprašanja.
The CHMP was concerned about the reliability of the study results following a routine inspection at the clinical study sites which revealed that the study had not been conducted in full compliance with Good Clinical Practice (GCP). 
Odbor CHMP je imel zadržke o zanesljivosti rezultatov študije zaradi rutinskega inšpekcijskega pregleda na lokacijah klinične študije, s katerim so odkrili, da študija ni bila v celoti opravljena v skladu z dobro klinično prakso.
In addition, the observed improvement in progression-free survival with Zemfirza was considered modest and there were concerns regarding the medicine's side effects, particularly diarrhoea and tiredness, which led to many patients stopping treatment early. 
Poleg tega je bilo opaženo izboljšanje preživetja brez napredovanja z zdravilom Zemfirza ocenjeno kot skromno in obstajali so pomisleki o neželenih učinkih zdravila, zlasti driski in utrujenosti, zaradi česar so številne bolnice predčasno prekinile zdravljenje.
On 19 September 2016, AstraZeneca AB officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zemfirza, for the treatment of ovarian cancer. 
Družba AstraZeneca AB je dne 19. septembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Zemfirza, namenjenim zdravljenju raka jajčnikov.