natgillin/translations-raw huggingface dataset:
Nivolumab BMS must be administered with caution in patients with moderate (total bilirubin > 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin > 3 × ULN and any AST) hepatic impairment. 
Pri bolnikih z zmerno (vrednost skupnega bilirubina > 1,5 × do 3 × zgornja meja normalne vrednosti [ZMN] in katera koli vrednost AST) ali s hudo (vrednost skupnega bilirubina > 3 × ZMN in katera koli vrednost AST) okvaro jeter je treba zdravilo Nivolumab BMS uporabljati previdno.
Nivolumab must be permanently discontinued for any severe immune related adverse reaction that recurs and for any life threatening immune related adverse reaction. 
Če se kateri koli resni imunsko pogojeni neželeni učinek ponovi, ali pojavi kateri koli resni imunsko pogojeni neželeni učinek, ki ogrozi življenje, je treba zdravljenje z nivolumabom trajno ukiniti.
Nivolumab BMS can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting to concentrations as low as 1 mg/mL. 
brez redčenja, po prenosu v infuzijski vsebnik z ustrezno sterilno injekcijsko brizgo, ali po redčenju do najnižje koncentracije 1 mg/ml.
Very common increased AST,bincreased ALT,b increased alkaline phosphatase,b increased creatinine,b decreased lymphocytes,b decreased platelet count,b decreased haemoglobin,b hypercalcaemia,b hypocalcaemia,b hyperkalaemia,b hypokalaemia,b hypomagnesaemia,b hyponatraemiab 
Bolezni mišično-skeletnega sistema in vezivnega tkiva tubulointersticijski nefritis, odpoved ledvic Splošne težave in spremembe na mestu aplikacije zvišanje vrednosti ASTb, zvišanje vrednosti ALTb, zvišanje vrednosti alkalne fosfatazeb, zvišanje vrednosti kreatininab, zmanjšanje števila limfocitovb, zmanjšanje števila trombocitovb, zmanjšanje vrednosti hemoglobinab, hiperkalciemijab, hipokalciemijab, hiperkaliemijab, hipokaliemijab,
Non-corticosteroid immunosuppressive therapy should be added if there is worsening or no improvement despite corticosteroid use. 
Če se stanje kljub uporabi kortikosteroida poslabša ali ne izboljša, je treba dodatno uvesti še nekortikosteroidno imunosupresivno zdravljenje.
Depending on your dose, the appropriate amount of Nivolumab BMS will be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection before use. 
Odvisno od potrebnega odmerka bodo ustrezno količino zdravila Nivolumab BMS pred uporabo razredčili z 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje ali s 5-odstotno
For symptomatic hyperthyroidism, nivolumab should be withheld and methimazole should be initiated as needed. 
V primeru simptomatskega hipertiroidizma je treba zdravljenje z nivolumabom zadržati in po potrebi uvesti zdravljenje z metimazolom.
Tell your doctor if you are on a low-sodium (low-salt) diet before you are given Nivolumab BMS. 
Če ste na dieti z nadzorovanim vnosom natrija (soli), o tem pred prvim prejemom zdravila
To further investigate the associative analyses between PDL-1 and PDL-2 expression conducted in Study CA209-066. 
Dodatno raziskati analize povezave med ekspresijo PDL-1 in PDL-2,
If applicable, dilute with the required volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection. 
Po potrebi koncentrat razredčite s potrebno količino 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje ali 5-odstotne (50 mg/ml) raztopine glukoze za injiciranje.
Fertility studies have not been performed with nivolumab. 
Študij o vplivu nivolumaba na plodnost niso izvedli.
For Grade 2 (symptomatic) pneumonitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents. 
V primeru pljučnice stopnje 2 (simptomatska) je treba zdravljenje z nivolumabom zadržati in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 mg/kg/dan metilprednizolona.
For Grade 2 or 3 serum creatinine elevation, nivolumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents. 
V primeru zvišanja serumskega kreatinina stopnje 2 ali 3 je treba zdravljenje z nivolumabom zadržati in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 0,5 do 1 mg/kg/dan metilprednizolona.
Table 2: Adverse reactions in patients with squamous NSCLC treated with nivolumab 3 mg/kg (CA209017 and CA209063) 
Preglednica 2: Neželeni učinki pri bolnikih s ploščatoceličnim NSCLC, ki so se zdravili z nivolumabom v odmerku 3 mg/kg (študija CA209017 in študija CA209063) Infekcijske in parazitske bolezni občasni bronhitis, okužba zgornjih dihal
Nivolumab BMS infusion 
Nivolumab BMS.
Severe rash should be managed with high-dose corticosteroid at a dose of 1 to 2 mg/kg/day prednisone equivalents. 
V primeru hudega izpuščaja je treba uvesti zdravljenje z visokim odmerkom kortikosteroidov v odmerku, ki ustreza 1 do 2 mg/kg/dan prednizona.
Immune-related nephritis and renal dysfunction 
Imunsko pogojeni nefritis in okvara delovanja ledvic
In CA209017 and CA209063, the incidence of rash was 12.1% (30/248). 
V študijah CA209017 in CA209063 je pojavnost izpuščaja znašala 12,1 % (30/248).
No Grade 4 or 5 nephritis or renal dysfunction was reported in these studies. 
O primerih nefritisa ali okvare delovanja ledvic stopnje 4 ali 5 v teh študijah
Severe nephritis or renal dysfunction has been observed with nivolumab treatment (see section 4.8). 
Pri zdravljenju z nivolumabom so poročali o hudem nefritisu ali okvari delovanja ledvic (glejte poglavje 4.8).
The pharmacokinetics (PK) of nivolumab is linear in the dose range of 0.1 to 10 mg/kg. 
V razponu odmerkov od 0,1 do 10 mg/kg je farmakokinetika nivolumaba linearna.
The Adverse Reaction Management Guide shall contain the following key elements: 
• Priročnik za ukrepanje v primeru pojava neželenih učinkov Priročnik za ukrepanje v primeru pojava neželenih učinkov mora vsebovati naslednje ključne
o Immune-related nephritis or renal dysfunction 
o imunsko pogojeni nefritis ali okvaro delovanja ledvic
Nivolumab BMS concentrate is a clear to opalescent, colourless to pale yellow liquid that 
Koncentrat zdravila Nivolumab BMS je bistra do opalescentna,
Your doctor will continue giving you Nivolumab BMS for as long as you keep benefitting from it or until you no longer tolerate the treatment. 
bo trajalo dokler bo prisotna njegova korist oziroma dokler boste zdravilo prenašali.
In CA209017 and CA209063, the incidence of nephritis or renal dysfunction was 3.2% (8/248). 
V študijah CA209017 in CA209063 je pojavnost nefritisa ali okvare delovanja ledvic znašala 3,2 % (8/248).
If worsening or no improvement occurs despite initiation of corticosteroids, nivolumab must be permanently discontinued. 
Če se stanje kljub uvedbi zdravljenja s kortikosteroidi poslabša ali ne izboljša, je treba zdravljenje z
For symptomatic hypophysitis, nivolumab should be withheld, and hormone replacement should be initiated as needed. 
V primeru simptomatskega vnetja hipofize je treba zdravljenje z nivolumabom zadržati in po potrebi uvesti zdravljenje z nadomeščanjem hormonov.
In CA209017 and CA209063, the incidence of diarrhoea or colitis was 9.3% (23/248). 
V študijah CA209017 in CA209063 je pojavnost driske ali kolitisa znašala 9,3 % (23/248).
If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and nivolumab must be permanently discontinued. 
Če se stanje kljub uvedbi zdravljenja s kortikosteroidi poslabša ali ne izboljša, je treba odmerek kortikosteroida povečati do odmerka, ki ustreza 2 do 4 mg/kg/dan metilprednizolona, zdravljenje z
Nivolumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy. 
Dokler bolnik prejema imunosupresivne odmerke kortikosteroidov ali drugih zdravil za zaviranje imunske odzivnosti, se zdravljenje z nivolumabom ne sme nadaljevati.
For Grade 4 serum creatinine elevation, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. 
V primeru zvišanja serumskega kreatinina stopnje 4 je treba zdravljenje z nivolumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
Persistent diarrhoea or colitis should be managed with corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents. 
Če driska ali kolitis ne mineta, je treba uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 0,5 do 1 mg/kg/dan metilprednizolona.
Caution should be used when considering the use of nivolumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immunestimulatory anticancer agents. 
Pri bolnikih z resnimi ali s smrtno nevarnimi kožnimi neželenimi učinki pri predhodnem zdravljenju raka z drugimi zdravili za imunsko stimulacijo je treba možnost uporabe nivolumaba previdno
Grade 2 and Grade 3 cases were reported in 2.8% (7/248) and 1.6% (4/248) of patients, respectively. 
O primerih stopnje 2 so poročali pri 2,8 % (7/248) bolnikov, o primerih stopnje 3 pa pri 1,6 % (4/248) bolnikov.
To be taken into consideration when treating patients on a controlled sodium diet. 
To je treba upoštevati pri bolnikih, ki so na
Monitoring of adrenal function and hormone levels should continue to ensure appropriate corticosteroid replacement is utilised. 
Za zagotovitev, da je zdravljenje z nadomeščanjem kortikosteroidov ustrezno, je treba kontinuirano nadzirati delovanje nadledvičnih žlez in vrednosti hormonov.
For symptomatic hypothyroidism, nivolumab should be withheld, and thyroid hormone replacement should be initiated as needed. 
V primeru simptomatskega hipotiroidizma je treba zdravljenje z nivolumabom zadržati in po potrebi uvesti zdravljenje z nadomeščanjem ščitničnega hormona.
For symptomatic diabetes, nivolumab should be withheld, and insulin replacement should be initiated as needed. 
V primeru simptomatske sladkorne bolezni je treba zdravljenje z nivolumabom zadržati in po potrebi uvesti zdravljenje z insulinom.
Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. 
Nivolumab prepreči vezavo ligandov PD-L1 in PD-L2 na receptor PD-1 in tako okrepi T-celični odziv, vključno s protitumorskim odzivom.
Grade 2 and Grade 3 cases were reported in 1.6% (4/248) and 0.8% (2/248) of patients, respectively. 
O primerih stopnje 2 so poročali pri 1,6 % (4/248) bolnikov, o primerih stopnje 3 pa pri 0,8 % (2/248) bolnikov.
In CA209017 and CA209063, the incidence of liver function test abnormalities was 1.2% (3/248). 
V študijah CA209017 in CA209063 je pojavnost nenormalnih izvidov delovanja jeter znašala 1,2 % (3/248).
Infections and infestations 
nadledvičnih žlez in sladkorno boleznijo)
Grade 2 and Grade 3 cases were reported in 1.2% (3/248) and 0.4% (1/248) of patients, respectively. 
O primerih stopnje 2 so poročali pri 1,2 % (3/248) bolnikov, o primerih stopnje 3 pa pri 0,4 % (1/248) bolnikov.
Monitoring of pituitary function and hormone levels should continue to ensure appropriate hormone replacement is utilised. 
Za zagotovitev, da je zdravljenje z nadomeščanjem hormonov ustrezno, je treba kontinuirano nadzirati delovanje hipofize in vrednosti hormonov.
For Grade 3 or 4 pneumonitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents. 
V primeru pljučnice stopnje 3 ali 4 je treba zdravljenje z nivolumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 2 do 4 mg/kg/dan metilprednizolona.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Uporaba nivolumaba je povezana s pojavom imunsko pogojenih neželenih učinkov.
Systemic immunosuppression 
Imunsko pogojeni izpuščaj
Grade 2 and Grade 3 cases were reported in 2% (5/248) and 1.6% (4/248) of patients, respectively. 
O primerih stopnje 2 so poročali pri 2 % (5/248) bolnikov, o primerih stopnje 3 pa pri 1,6 % (4/248) bolnikov.
Permanently discontinue Nivolumab BMS 
Nivolumab BMS trajno ukinite.
For Grade 3 diarrhoea or colitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. 
V primeru driske ali kolitisa stopnje 3 je treba zdravljenje z nivolumabom zadržati in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
The total dose of Nivolumab BMS required can be infused directly as a 10 mg/mL solution or can be diluted to as low as 1 mg/mL with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection. 
Celotni potrebni odmerek zdravila Nivolumab BMS se lahko infundira neposredno v obliki raztopine s koncentracijo 10 mg/ml ali pa se ga predhodno razredči do najnižje koncentracije 1 mg/ml z
Withhold Nivolumab BMS until laboratory values return to baseline and management with corticosteroids, if needed, is complete 
zadržite dokler se laboratorijske vrednosti ne povrnejo do izhodiščnih vrednosti in zdravljenje s kortikosteroidi,
th 
V
MARKETING AUTHORISATION HOLDER 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Three patients, including 2 patients with a Grade 3 case, received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 0.6 mg/kg (range: 0.4-1.3) for a median duration of 2.0 weeks (range: 1.4-14.1). 
40 mg prednizona) z medianim začetnim odmerkom 0,6 mg/kg (razpon: 0,4-1,3), zdravljenje pa je mediano trajalo 2,0 tedna (razpon: 1,4-14,1).
Severe diarrhoea or colitis has been observed with nivolumab treatment (see section 4.8). 
Pri zdravljenju z nivolumabom so poročali o hudi driski ali kolitisu (glejte poglavje 4.8).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nivolumab BMS 10 mg/mL sterile concentrate nivolumab 
Nivolumab BMS 10 mg/ml sterilni koncentrat
Underactive thyroid gland which can cause tiredness or weight gain Inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs, headache, dizziness 
Bolezni imunskega sistema občasni anafilaktična reakcija, preobčutljivost, reakcije, povezane z infundiranjem insuficienca nadledvičnih žlez, vnetje ščitnice periferna nevropatija, glavobol, omotica
For Grade 4 diarrhoea or colitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. 
V primeru driske ali kolitisa stopnje 4 je treba zdravljenje z nivolumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
Immune-related nephritis or renal dysfunction present with asymptomatic increases in serum creatinine. 
Večina bolnikov je imela le asimptomatsko zvišano vrednost serumskega kreatinina.
STEP 1 
KORAK
Check with your doctor or nurse before you are given Nivolumab BMS if: you have been told that your cancer has spread to your brain you have an autoimmune disease (a condition where the body attacks its own cells); you have any history of inflammation of the lungs; you have been taken medicines to suppress your immune system. 
Preden boste prvič prejeli zdravilo Nivolumab BMS se posvetujte z zdravnikom ali medicinsko če vam je zdravnik povedal, da se je rak razširil v možgane.
Post-authorisation efficacy study (PAES): The MAH should submit an updated OS data for Study CA209017: a Phase 3, randomized study of nivolumab vs docetaxel in subjects with advanced or metastatic squamous NSCLC who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen. 
Študija učinkovitosti po pridobitvi dovoljenja za promet (PAES): Imetnik dovoljenja za promet z zdravilom mora predložiti dopolnjene podatke o celokupnem preživetju za študijo CA209017: randomizirana študija faze 3
STATEMENT OF ACTIVE SUBSTANCE(S) Each mL of concentrate contains 10 mg of nivolumab. 
En ml koncentrata vsebuje 10 mg nivolumaba.
Upon improvement, nivolumab may be resumed after corticosteroid taper, if needed. 
Po izboljšanju in postopnem zmanjšanju odmerka kortikosteroida, če je bilo takšno zdravljenje potrebno, se zdravljenje z nivolumabom lahko nadaljuje.
Monitoring of thyroid function should continue to ensure appropriate hormone replacement is utilised. 
Za zagotovitev, da je hormonsko nadomestno zdravljenje ustrezno, je treba kontinuirano
Grade 3 or 4 pneumonitis 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Three patients, including the one patient with Grade 3 adrenal insufficiency, received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 1.1 mg/kg (range: 0.5-1.3) for 2.7 weeks (range: 0.6-4.6). 
Trije bolniki, vključno z enim bolnikom z insuficienco nadledvičnih žlez stopnje 3, so prejemali visoke odmerke kortikosteroidov (odmerke, ki so ustrezali vsaj 40 mg prednizona) z medianim začetnim odmerkom
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Vrednotenje tumorja na osnovi različice 1.1 kriterijev za vrednotenje odziva pri solidnih tumorjih (RECIST v1.1, Response Evaluation Criteria in Solid
Immune-related adverse reaction 
Imunsko pogojeni neželeni učinek
Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 2222 
Tel: + 31 (0)30 300 2222
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections 
polisorbat 80, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
Common 
Dogodki
More than one vial of Nivolumab BMS may be necessary to obtain the required dose. 
Za potreben odmerek bo morda treba uporabiti več kot
After administration of the nivolumab dose, flush the line with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection. 
0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje ali s 5-odstotno (50 mg/ml)
No Grade 4 or 5 rash was reported in these studies. 
izpuščaju stopnje 4 ali 5 v teh študijah niso poročali.
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 40 (0)21 272 16 00 
Tel: + 40 (0)21 272 16 00
Nivolumab BMS should be continued in the presence of hormone replacement therapy a as long as no symptoms are present 
Če med hormonskim nadomestnim zdravljenjem a simptomi niso prisotni, je treba zdravljenje z zdravilom Nivolumab BMS nadaljevati.
Gently mix the infusion by manual 
Raztopino za infundiranje z vrtenjem v rokah nežno premešajte.
The patient takes one capsule one hour before starting each chemotherapy cycle. 
Bolnik mora vzeti eno kapsulo eno uro pred začetkom vsakega cikla kemoterapije.
One of the active substances, palonosetron, has been authorised on its own in the EU since 2005. 
Ena od zdravilnih učinkovin, palonosetron, je v EU samostojno odobrena od leta 2005.
The Committee therefore concluded that the medicine's benefits are greater than its risk and recommended that it be approved for use in the EU. 
Odbor je zato zaključil, da so koristi zdravila večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The European Commission granted a marketing authorisation valid throughout the European Union for Akynzeo on 27 May 2015 
Evropska komisija je dovoljenje za promet z zdravilom Akynzeo, veljavno po vsej Evropski uniji, izdala 27. maja 2015.
The full EPAR and risk management plan summary for Akynzeo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Akynzeo sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Akynzeo. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Akynzeo.
What measures are being taken to ensure the safe and effective use of Akynzeo? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Akynzeo?
Other information about Akynzeo 
Druge informacije o zdravilu Akynzeo
Akynzeo netupitant / palonosetron hydrochloride 
Akynzeo netupitant/palonosetronijev klorid
This study involved 1,455 patients and the patients took dexamethasone, another medicine used to prevent vomiting, as an additional treatment. 
V tej študiji je sodelovalo 1455 bolnikov, ki so kot dopolnilno zdravljenje prejemali tudi deksametazon, drugo zdravilo, ki se uporablja za preprečevanje bruhanja.
A risk management plan has been developed to ensure that Akynzeo is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Akynzeo je bil pripravljen načrt obvladovanja tveganj.
The most common side effects reported with Akynzeo are headache (seen in 3.6% of patients), constipation (3.0%) and fatigue (1.2%). 
Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Akynzeo, so glavobol (ki so ga opazili pri 3,6 % bolnikov), zaprtost (3,0 %) in utrujenost (1,2 %).
Akynzeo is available as capsules containing 300 mg of netupitant and 0.5 mg of palonosetron. 
Zdravilo Akynzeo je na voljo v obliki kapsul, ki vsebujejo 300 mg netupitanta in 0,5 mg palonosetrona.
What benefits of Akynzeo have been shown in studies? 
Kakšne koristi je zdravilo Akynzeo izkazalo v študijah?
For more information about treatment with Akynzeo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Akynzeo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A second main study looked at the benefits of Akynzeo in patients undergoing moderately emetogenic chemotherapy. 
V drugi glavni študiji so proučevali koristi zdravila Akynzeo pri bolnikih, ki prejemajo zmerno emetogeno kemoterapijo.
In a main study comparing Akynzeo with palonosetron alone, 90% of patients taking Akynzeo (121 out of 135) experienced no vomiting within 5 days of starting highly emetogenic chemotherapy compared with 77% of patients taking palonosetron alone (104 out of 136). 
V glavni študiji, v kateri so zdravilo Akynzeo primerjali s samim palonosetronom, se bruhanje v 5 dneh po začetku zdravljenja z zelo emetogeno kemoterapijo ni pojavilo pri 90 % bolnikov, ki so jemali Akynzeo (121 od 135), v primerjavi s 77 % bolnikov, ki so jemali samo palonosetron (104 od 136).
Akynzeo is a medicine used to prevent nausea (feeling sick) and vomiting in adult patients with cancer who are receiving chemotherapy (medicines to treat cancer). 
Akynzeo je zdravilo, ki se uporablja za preprečevanje navzeje (slabosti) in bruhanja pri odraslih bolnikih z rakom, ki prejemajo kemoterapijo (zdravila za zdravljenje raka).
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Akynzeo was effective at preventing both the immediate and delayed phases of nausea and vomiting following chemotherapy, and that the medicine has a favourable safety profile. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je upošteval, da je zdravilo Akynzeo učinkovito preprečilo tako takojšnjo kot zapoznelo fazo slabosti in bruhanja po kemoterapiji in da ima ugoden varnostni profil.
What is Akynzeo and what is it used for? 
Kaj je zdravilo Akynzeo in za kaj se uporablja?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Akynzeo, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What are the risks associated with Akynzeo? 
Kakšna tveganja so povezana z zdravilom Akynzeo?