natgillin/translations-raw huggingface dataset:
AST increased, ALT increased, blood alkaline phosphatase increased 
Občasni zvišana AST, zvišana ALT, zvišana alkalna fosfataza v krvi
Dose reductions may be implemented based on adverse reactions. 
Na osnovi neželenih učinkov je mogoče odmerek zmanjšati.
Do not chew or crush the capsules. 
Kapsul ne smete žvečiti ali zdrobiti.
If a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption, Zejula should be discontinued. 
Če se pri bolnici razvije huda dolgotrajna hematološka toksičnost, vključno s pancitopenijo, ki ne izzveni v 28 dneh po prekinitvi zdravljenja, je treba zdravljenje z zdravilom Zejula ukiniti.
In the clinical programme, neutropenia was managed with laboratory monitoring and dose modifications (see section 4.2). 
kliničnem programu so nevtropenijo obvladovali z laboratorijskim spremljanjem in prilagajanjem odmerka (glejte poglavje 4.2).
Approximately 30 % of patients receiving Zejula experienced neutropenia of any grade, and 20 % of patients experienced Grade 3/4 neutropenia. 
Pri približno 30 % bolnic, ki so prejemale zdravilo Zejula, se je pojavila nevtropenija katere koli stopnje, pri 20 % bolnic pa se je pojavila nevtropenija 3. ali 4. stopnje.
Discontinuation due to hypertension occurred in < 1 % of patients. 
Do ukinitve zdravljenja zaradi hipertenzije je prišlo pri < 1 % bolnic.
Zejula contains lactose 
Zdravilo Zejula vsebuje laktozo
What Zejula is used for 
Za kaj uporabljamo zdravilo Zejula
Myelodysplastic syndrome/acute myeloid leukaemia Rarely, low blood-cell counts may be a sign of more serious problems with the bone marrow such as 
Mielodisplastični sindrom (MDS) ali akutna mieloična levkemija V redkih primerih so lahko nizka števila krvnih celic znak resnejših težav s kostnim mozgom, kot sta »mielodisplastični sindrom« (MDS) ali »akutna mieloična levkemija« (AML).
The median duration of thrombocytopenia events of any grade was 23 days, and the median duration of Grade 3/4 thrombocytopenia was 10 days. 
Mediani čas trajanja dogodkov trombocitopenije katere koli stopnje je bil 23 dni in mediani čas trajanja trombocitopenije 3. ali 4. stopnje je bil 10 dni.
If a patient develops severe persistent haematologic toxicity that does not resolve within 28 days following interruption, Zejula should be discontinued. 
Če se pri bolnici razvije huda dolgotrajna hematološka toksičnost, ki ne izzveni v 28 dneh po prekinitvi zdravljenja, je treba zdravljenje z zdravilom Zejula ukiniti.
If you take more than your normal dose, contact your doctor immediately. 
Če ste vzeli večji odmerek zdravila Zejula, kot bi smeli Takoj obvestite zdravnika, če ste vzeli več kot svoj običajni odmerek zdravila.
In the HRDpos group, the hazard ratio was 0.38 (95 % CI, 0.243, 0.586; p < 0.0001). 
V skupini, pozitivni za HRD, je bilo razmerje tveganja 0,38 (95-% IZ, 0,243, 0,586; p < 0,0001).
Confirmed diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukaemia 
Potrjena diagnoza mielodisplastičnega sindroma (MDS) ali akutne mieloične levkemije (AML)
• Inflammation of the mouth and/or digestive tract 
• vnetje v ustih in/ali prebavilih,
Zejula contains the active substance niraparib. 
Zdravilo Zejula vsebuje učinkovino niraparib.
If adverse reactions persist beyond a 28-day dose interruption, it is recommended that Zejula be discontinued. 
Če je neželeni učinek prisoten tudi po 28-dnevni prekinitvi zdravljenja, je priporočljivo zdravljenje z zdravilom Zejula ukiniti.
• Pink eye 
• rdeče oči (konjuktivitis),
In the clinical programme, anaemia was managed with laboratory monitoring, dose modification (see section 4.2), and where appropriate with red blood cell transfusions. 
V kliničnem programu so anemijo obvladovali z laboratorijskim spremljanjem, prilagajanjem odmerka (glejte poglavje 4.2) in, kjer je bilo primerno, s transfuzijami eritrocitov.
• Decreased appetite 
• glavobol, • zmanjšan apetit,
Reproductive and developmental toxicity studies have not been conducted with niraparib. 
Študije vpliva na sposobnost razmnoževanja in razvoj z niraparibom niso bile izvedene.
Dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis 
Pogosti suha usta, abdominalna distenzija, vnetje sluznic (vključno z mukozitisom),
There are no data in patients with severe renal impairment or end stage renal disease undergoing haemodialysis; use with caution in these patients (see section 5.2). 
Podatkov za bolnice s hudo okvaro ledvic ali končno ledvično odpovedjo, ki prejemajo hemodializo, ni; pri teh bolnicah zdravilo uporabljajte previdno (glejte poglavje 5.2).
Zejula has moderate influence on the ability to drive or use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Zejula ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
These findings occurred at exposure levels below those seen clinically, and were largely reversible within 4 weeks of cessation of dosing. 
Do teh ugotovitev je prišlo pri stopnjah izpostavljenosti, nižjih od stopenj klinične izpostavljenosti.
• Shortness of breath 
• pomanjkanje sape,
Hepatic impairment 
Občasni glavobol
• Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥ 1,500/µL or haemoglobin returns to ≥ 9 g/dL. 
28 dni in tedensko spremljajte število krvnih celic, dokler se število nevtrofilcev ne povrne na ≥ 1.500/µl oziroma se raven hemoglobina ne povrne na ≥ 9 g/dl.
The median time to onset of anaemia of any grade was 42 days, and 85 days for Grade 3/4 events. 
Mediani čas do nastopa anemije katere koli stopnje je bil 42 dni, do dogodka 3. ali 4. stopnje pa 85 dni.
Zejula 100 mg capsules niraparib 
IME ZDRAVILA Zejula 100 mg kapsule niraparib
Approximately 25 % of patients in the NOVA study weighed less than 58 kg, and approximately 25 % of patients weighed more than 77 kg. 
Bolnice z majhno telesno maso Približno 25 % bolnic v študiji NOVA je tehtalo manj kot 58 kg in približno 25 % bolnic je tehtalo več kot 77 kg. Pojavnost neželenih učinkov zdravila stopnje 3 ali 4 je bila višja pri bolnicah z majhno telesno maso (78 %) kot pri bolnicah z veliko telesno maso (53 %).
A starting dose of 200 mg for patients weighing less than 58 kg may be considered. 
58 kg, lahko razmislite o začetnem odmerku 200 mg.
Zejula should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy. 
Če nastopi hipertenzivna kriza ali pa medicinsko pomembne hipertenzije ni mogoče zadostno obvladati z zdravljenjem proti hipertenziji, je treba zdravljenje z zdravilom Zejula ukiniti.
Dyspnea, cough, nasopharyngitis 
Zelo pogosti dispneja, kašelj, nazofaringitis
B: Placebo 
Placebo
Zejula 100 mg hard capsules 
IME ZDRAVILA Zejula 100 mg trde kapsule
A sensitivity analysis of investigator PFS showed the following results for the gBRCAmut cohort: HR 0.27 (95 % CI*, 0.182, 0.401; p < 0.0001); median PFS 14.8 months (95% CI*, 12.0, 16.6) for niraparib and median PFS 5.5 months (95% CI*, 4.9, 7.2) for placebo, and for the non-gBRCAmut cohort: HR 0.53 (95 % CI*, 0.405, 0.683; p < 0.0001); median PFS 8.7 months (95 % CI*, 7.3, 10.0) for niraparib and median PFS 4.3 months (95% CI*, 3.7, 5.5) for placebo. 
0,182, 0,401; p < 0,0001); mediano PFS 14,8 meseca (95-% IZ*, 12,0, 16,6) za niraparib in mediano PFS 5,5 meseca (95-% IZ*, 4,9, 7,2) za placebo; za kohorto ne-gBRCAmut pa naslednje rezultate:
The median time to onset of neutropenia of any grade was 27 days, and 29 days for Grade 3/4 events. 
Mediani čas do nastopa nevtropenije katere koli stopnje je bil 27 dni, do dogodkov 3. ali 4. stopnje pa 29 dni.
No patients with pre-existing severe renal impairment or end-stage renal disease undergoing hemodialysis were identified in clinical studies (see section 4.2). 
V kliničnih študijah niso zabeležili bolnic s predhodno obstoječo hudo okvaro ledvic ali končno odpovedjo ledvic, ki so prejemale hemodializo (glejte poglavje 4.2).
No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OAT1 (e.g. probenecid) or OAT3 (e.g. probenecid, diclofenac), or OCT2 (e.g. cimetidine, quinidine) uptake transporters. 
Pri sočasnem dajanju zdravila Zejula z zdravili, za katera je znano, da zavirajo privzemne prenašalce OAT1 (npr. probenecid) ali OAT3 (npr. probenecid, diklofenak) ali OCT2 (npr. cimetidin, kvinidin), prilagoditev odmerka ni potrebna.
Zejula 100 mg hard capsules niraparib 
IME ZDRAVILA Zejula 100 mg trde kapsule niraparib
No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OATP1B1 or 1B3 (e.g. gemfibrozil, ritonavir), or OCT1 (e.g. dolutegravir) uptake transporters. 
Pri sočasnem dajanju zdravila Zejula z zdravili, za katera je znano, da zavirajo privzemne prenašalce OATP1B1 ali 1B3 (npr. gemfibrozil, ritonavir) ali OCT1 (npr. dolutegravir), prilagoditev odmerka ni potrebna.
The median duration of neutropenia of any grade was 26 days, and 13 days for Grade 3/4 events. 
Mediani čas trajanja nevtropenije katere koli stopnje je bil 26 dni, dogodkov 3. ali 4. stopnje pa 13 dni.
• Permanently discontinue Zejula. 
Trajno ukinite zdravljenje z zdravilom Zejula.
Approximately 60 % of patients receiving Zejula experienced thrombocytopenia of any grade, and 34 % of patients experienced Grade 3/4 thrombocytopenia. 
Trombocitopenija Pri približno 60 % bolnic, ki so prejemale zdravilo Zejula, se je pojavila trombocitopenija katere koli stopnje, pri 34 % bolnic pa se je pojavila trombocitopenija 3. ali 4. stopnje.
Demographics, baseline disease characteristics, and prior treatment history were generally well balanced between the niraparib and placebo arms in the gBRCAmut (n = 203) and the non-gBRCAmut cohorts (n = 350). 
Demografske značilnosti, izhodiščne lastnosti bolezni in anamneza predhodnih zdravljenj so bile na splošno dobro uravnotežene med krakoma z niraparibom in placebom v kohortah gBRCAmut
Myalgia 
mialgija
No dose adjustment is needed in patients with mild to moderate hepatic impairment. 
Pri bolnicah z blago do zmerno okvaro jeter prilagoditev odmerka ni potrebna.
Therefore, the PRAC concluded that “febrile neutropenia” should be added as a new adverse drug reaction in section 4.8 of the SmPC with the frequency “uncommon.” The package leaflet should be updated accordingly. 
Zato je odbor PRAC sklenil, da je treba v poglavju 4.8 povzetka glavnih značilnosti zdravila dodati nov neželeni učinek
If you are a woman who could become pregnant you must use reliable contraception while you are taking Zejula, and you must continue to use reliable contraception for 1 month after taking your last dose. 
Če ste ženska v rodni dobi, morate uporabljati učinkovito kontracepcijo, dokler jemljete zdravilo Zejula in še 1 mesec po tem, ko ste vzeli zadnji odmerek.
• Resume Zejula at a reduced dose. 
Ponovno začnite zdravljenje z zdravilom Zejula z zmanjšanim odmerkom.
Oxidative metabolism of niraparib is minimal in vivo. 
Oksidativna presnova nirapariba in vivo je minimalna.
Therefore, no dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit P-gp (e.g. amiodarone, verapamil) or BCRP (e.g. osimertinib, velpatasvir, and eltrombopag). 
Zato pri sočasnem dajanju zdravila Zejula z zdravili, za katera je znano, da zavirajo P-gp (npr. amiodaron, verapamil) ali BCRP (npr. osimertinib, velpatasvir in eltrombopag), prilagoditev odmerka ni potrebna.
If there are other risk factors for bleeding such as co-administration of anticoagulation or antiplatelet medicinal products, consider interrupting these substances and/or transfusion at a higher platelet count. 
Če so prisotni drugi dejavniki tveganja za krvavitev, kot je sočasno dajanje antikoagulacijskih ali antiagregacijskih zdravil,
Niraparib is eliminated primarily through the hepatobiliary and renal routes. 
Niraparib se primarno izloča prek jeter, žolčnika in žolčevodov ter ledvic.
Clinic visits occurred each cycle (4 weeks ± 3 days). 
Obiski na kliniki so se odvijali v vsakem ciklu
• Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥ 100,000/µL. 
Prekinite zdravljenje z zdravilom Zejula za največ 28 dni in tedensko spremljajte število krvnih celic, dokler se število trombocitov ne povrne na ≥ 100.000/µl.
The study met its primary objective of statistically significantly improved PFS for niraparib maintenance monotherapy compared with placebo in the gBRCAmut cohort (HR 0.27; 95 % CI* 0.173, 0.410; p < 0.0001) as well as in the overall non-gBRCAmut cohort (HR 0.45; 95 % CI* 0.338, 0.607; p < 0.0001). 
Študija je dosegla svoj primarni cilj statistično značilnega izboljšanja PFS za vzdrževalno monoterapijo z niraparibom v primerjavi s placebom v kohorti gBRCAmut (HR 0,27; 95-% IZ* 0,173,
Hazard ratio (95 % CI) *CI denotes confidence interval, gBRCAmut germline BRCA mutation, and NR not reached 
*IZ pomeni interval zaupanja, gBRCAmut pomeni zarodno mutacijo BRCA, ND pomeni »ni doseženo«.
Dyspnea 
dispepsija
Nausea, vomiting, abdominal pain 
Pogosti navzea, bruhanje, bolečina v trebuhu
Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in a small number of patients who received Zejula or placebo. 
Pri majhnem številu bolnic, ki so prejele zdravilo Zejula ali placebo, so poročali o mielodisplastičnem sindromu/akutni mieloični levkemiji (MDS/AML), vključno s primeri s smrtnim izidom.
Haematologic adverse reactions have been observed during the treatment with Zejula especially during the initial phase of the treatment. 
Preglednica 2: Prilagajanje odmerka zaradi hematoloških neželenih učinkov Med zdravljenjem z zdravilom Zejula so opazili hematološke neželene učinke, zlasti v začetni fazi zdravljenja.
Common (may affect up to 1 in 10 people) Reduction in the number of white cells in the blood (leukopenia) Talk to your doctor if you get any other side effects. 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnic): • Znižanje števila belih krvničk v krvi (levkopenija).
Inhibition of hepatic uptake transporters (OATP1B1, OATP1B3, and OCT1) Neither niraparib nor M1 is an inhibitor of organic anion transport polypeptide 1B1 (OATP1B1) or 1B3 (OATP1B3). 
Zaviranje prenašalcev jetrnega privzema (OATP1B1, OATP1B3 in OCT1) Niraparib in M1 nista zaviralca organskega anionskega prenašalnega polipeptida 1B3 (OATP1B1) ali 1B3 (OATP1B3).
Patients began treatment on Cycle 1/Day 1 (C1/D1) with niraparib 300 mg or matched placebo administered QD in continuous 28-day cycles. 
dnevu s 300 mg nirapariba ali ujemajočim se placebom, danim enkrat dnevno v kontinuiranih 28-dnevnih ciklih.
No dose adjustment is necessary for patients with mild to moderate renal impairment. 
Pri bolnicah z blago do zmerno okvaro ledvic prilagoditev odmerka ni potrebna.
Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg of niraparib. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje niraparibijev tosilat monohidrat v količini, ki ustreza 100 mg nirapariba.
Insomnia, anxiety, depression 
Zelo pogosti nespečnost Pogosti anksioznost, depresija
Back pain, arthralgia 
Občasni bolečina v hrbtu, artralgija,
No effect on behavioural and/or neurological parameters have been observed in repeat-dose toxicity studies in rats and dogs at estimated CNS exposure levels similar to or below expected therapeutic exposure levels. 
podobnih pričakovanim terapevtskim ravnem izpostavljenosti ali nižjih, niso opazili vpliva na vedenjske in/ali nevrološke parametre.
In the clinical programme, thrombocytopenia was managed with laboratory monitoring, dose modification and platelet transfusion where appropriate (see section 4.2). 
V kliničnem programu so trombocitopenijo obvladovali z laboratorijskim spremljanjem, prilagajanjem odmerka in, če je bilo to primerno, s transfuzijo trombocitov (glejte poglavje 4.2).
Thrombocytopenia, anaemia, neutropenia 
Zelo pogosti trombocitopenija, anemija, nevtropenija
• 56 × 1 hard capsules 
• 56 × 1 trdo kapsulo • 28 × 1 trdo kapsulo
Niraparib as a substrate of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 is a substrate of organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2). 
Niraparib kot substrat ledvičnih privzemnih prenašalcev (OAT1, OAT3 in OCT2) Niraparib in M1 nista substrata organskega anionskega prenašalca 1 (OAT1), 3 (OAT3) in organskega kationskega prenašalca 2 (OCT2).
Non-gBRCAmut cohort niraparib (N = 138) 
(n = 203) in ne-gBRCAmut (n = 350).
Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) have been reported in patients treated with Zejula. 
Pri bolnicah, zdravljenih z zdravilom Zejula, so poročali o hematoloških neželenih učinkih (trombocitopeniji, anemiji, nevtropeniji).
• Stomach pain 
• bolečina v trebuhu,
Hypertension, including hypertensive crisis, has been reported with Zejula therapy. 
Pri zdravljenju z zdravilom Zejula so poročali o hipertenziji, vključno s hipertenzivno krizo.
Hypertension, including hypertensive crisis, has been reported with the use of Zejula. 
Pri uporabi zdravila Zejula so poročali o hipertenziji, vključno s hipertenzivno krizo.
Headache, dizziness, dysgeusia 
Zelo pogosti glavobol, omotičnost, disgevzija
Inhibition of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 inhibits organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2). 
Zaviranje prenašalcev ledvičnega privzema (OAT1, OAT3 in OCT2) Niraparib in M1 ne zavirata organskega anionskega prenašalca 1 (OAT1), 3 (OAT3) in organskega kationskega prenašalca 2 (OCT2).
The safety and efficacy of niraparib as maintenance therapy was studied in a Phase 3 randomised, double-blind, placebo-controlled international trial (ENGOT-OV16 / NOVA) in patients with relapsed predominantly high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by complete response (CR) or partial response (PR) for more than six months to their penultimate (next to last) platinum-based therapy. 
jajcevoda ali primarnega peritonealnega raka visoke stopnje, ki je bil občutljiv na platino, kar je bilo opredeljeno kot popoln odziv (PO) ali delni odziv (DO) na njihovo predzadnje zdravljenje na osnovi platine, ki je trajal več kot šest mesecev.
• Indigestion 
• omotičnost,
No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit (e.g. itraconazole, ritonavir, and clarithromycin) or induce CYP enzymes (e.g. rifampin, carbamazepine, and phenytoin). 
Pri sočasnem dajanju zdravila Zejula z zdravili, za katera je znano, da zavirajo (npr. itrakonazol, ritonavir in klaritromicin) ali spodbujajo
Your doctor may recommend a lower dose if you experience side effects (such as nausea, tiredness, abnormal bleeding/bruising, anaemia). 
Če se pri vas pojavijo neželeni učinki (kot so siljenje na bruhanje (navzea), utrujenost, nenormalna krvavitev/modrice, anemija), bo zdravnik morda priporočil manjši odmerek.
Niraparib as a substrate of CYPs (CYP1A2 and CYP3A4) Niraparib is a substrate of carboxylesterases (CEs) and UDP-glucuronosyltransferases (UGTs) in vivo. 
Niraparib je in vivo substrat karboksilesteraz (CE, carboxylesterases) in UDP-glukuronoziltransferaz (UGT).
Low blood-cell counts 
Nizka števila krvnih celic
Tachycardia 
CTCAE
Capsule content Magnesium stearate 
Občasni fotosenzitivnost, izpuščaj
What Zejula is and what it is used for What you need to know before you take Zejula How to take Zejula 
Kaj morate vedeti, preden boste vzeli zdravilo Zejula
There are limited clinical data in patients aged 75 or over. 
75 let, so omejeni.
In patients with baseline platelet count less than 180 × 109/L, thrombocytopenia of any grade and Grade 3/4 occurred in 76 % and 45 % of the patients, respectively. 
Pri bolnicah z izhodiščnim številom trombocitov manj kot 180 × 109/l se je trombocitopenija katere koli stopnje oziroma 3. ali
Gamma-glutamyl transferase increased * Frequencies are based on percent of patients using all-causality adverse events. 
* Pogostnosti temeljijo na odstotku bolnic ob upoštevanju neželenih dogodkov vseh vzrokov.
Estimated Survival Function 
- Navodilo shranite.
Very common 
Pogosti dispneja
Urinary tract infection, bronchitis 
Infekcijske in parazitske bolezni Zelo pogosti okužba sečil Pogosti bronhitis, konjunktivitis
Name and address of the manufacturer(s) responsible for batch release Manufacturing Packaging Farmaca (MPF) B.V. Appelhof 13 
Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
A. 
IZ)
How to store Zejula 
Shranjevanje zdravila Zejula
Back pain, arthralgia, myalgia 
Zelo pogosti bolečina v hrbtu, artralgija Pogosti mialgija
Lactose 
stomatitis
Lactose monohydrate 
Pogosti hipertenzija
The median duration of anaemia of any grade was 63 days, and 8 days for Grade 3/4 events. 
Mediani čas trajanja anemije katere koli stopnje je bil 63 dni, dogodkov
Reproductive toxicology 
Toksikologija vpliva na sposobnost razmnoževanja
Nervous system disorders 
• prebavne motnje,
Neither niraparib nor M1 is a substrate of organic anion transport polypeptide 1B1 (OATP1B1), 1B3 (OATP1B3), or organic cation transporter 1 (OCT1). 
Niraparib kot substrat jetrnih privzemnih prenašalcev (OATP1B1, OATP1B3 in OCT1) Niraparib in M1 nista substrata organskega anionskega prenašalnega polipeptida 1B1 (OATP1B1), 1B3 (OATP1B3) ali organskega kationskega prenašalca 1 (OCT1).
• Abdominal bloating 
• siljenje na bruhanje,
Ελλάδα 
• izpuščaj,
10 June 2016 
10. junij 2016
The European Commission issued a decision on 10 June 2016. 
Evropska komisija je sklep izdala 10. junija 2016.
The company requested the authorisation to be recognised in Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom (the ‘concerned Member States'). 
Želela je priznanje dovoljenja za promet v Bolgariji, na Hrvaškem, v Franciji, Nemčiji, na Irskem, v Italiji, na Nizozemskem, Poljskem, Portugalskem, v Romuniji, Sloveniji, Španiji in Združenem kraljestvu („zadevne države članice“).
However, the Member States could not reach an agreement and the Belgian Federal Agency for Medicines and Health Products referred the matter to the CVMP for arbitration on 29 September 2015. 
Vendar države članice niso mogle doseči soglasja, zato je belgijska zvezna agencija za zdravila in zdravstvene izdelke 29. septembra 2015 zadevo napotila na odbor CVMP v arbitražo.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that subject to the conduct of additional studies and the implementation of further measures specified in a Risk Management Plan the marketing authorisation for CattleMarker IBR Inactivated should be granted in all concerned Member States. 
Na osnovi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj odbora je odbor CVMP zaključil, da se pod pogojem, da bodo opravljene dodatne študije in izvedeni nadaljnji ukrepi, opredeljeni v načrtu za obvladovanje tveganj, dovoljenje za promet s cepivom CattleMarker IBR Inactivated izda v vseh zadevnih državah članicah.
On 17 March 2016, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated). 
Evropska agencija za zdravila je 17. marca 2016 zaključila postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede izdaje dovoljenja za promet s cepivom CattleMarker IBR Inactivated emulzija za injiciranje za govedo (v nadaljnjem besedilu: CattleMarker IBR Inactivated).
Why was CattleMarker IBR Inactivated reviewed? 
Zakaj je bilo cepivo CattleMarker IBR Inactivated pregledano?