natgillin/translations-raw huggingface dataset:
For Grade 3 or 4 pneumonitis, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents. 
Pri pneumonitíde 3. alebo 4. stupňa sa musí liečba nivolumabom alebo nivolumabom v kombinácii s ipilimumabom natrvalo ukončiť a má sa začať liečba kortikosteroidmi v dávke zodpovedajúcej metylprednizolónu 2 až 4 mg/kg/deň.
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of liver function test abnormalities was 29.5% (132/448). 
U pacientov liečených nivolumabom v dávke 1 mg/kg v kombinácii s ipilimumabom v dávke 3 mg/kg pri melanóme bola incidencia abnormalít testov funkcie pečene 29,5
For Grade 3 or 4 transaminase or total bilirubin elevation, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. 
Pri vzostupe transamináz alebo celkového bilirubínu 3. alebo 4. stupňa sa musí liečba nivolumabom alebo nivolumabom v kombinácii s ipilimumabom natrvalo ukončiť a má sa začať liečba kortikosteroidmi v dávke zodpovedajúcej metylprednizolónu 1 až 2 mg/kg/deň.
Resolution occurred in 132 patients (76.7%) with a median time to resolution of 5.9 weeks (range: 0.1-82.6+). 
%) s mediánom času do vyriešenia 5,9 týždňa (rozsah: 0,1 - 82,6+).
Probability of Recurrence-Free Survival 
Pravdepodobnosť prežívania bez rekurencie ochorenia
Severe nephritis and renal dysfunction have been observed with monotherapy treatment or nivolumab in combination with ipilimumab (see section 4.8). 
Pri liečbe monoterapiou alebo pri nivolumabe v kombinácii s ipilimumabom sa pozorovali závažná nefritída a dysfunkcia obličiek (pozri časť 4.8).
The majority of cases were Grade 1 in severity reported in 20.1% (518/2578) of patients. 
Väčšina hlásených prípadov bola 1. stupňa závažnosti u 20,1
Nivolumab 3 mg/kg (events: 184/240), median and 95% CI: 7.72 (5.68,8.77) Investigator's choice (events: 105/121), median and 95% CI: 5.06 (4.04, 6.24) 
Nivolumab 3 mg/kg (príhody: 184/240), medián a 95 % CI: 7,72 (5,68; 8,77)
Uncommon dehydration, metabolic acidosis Not known tumour lysis syndromei Hepatobiliary disorders Uncommon hepatitisc Rare cholestasis 
Neznáme syndróm spôsobený rozpadom nádorui Poruchy pečene a žlčových ciest Menej časté hepatitídac Zriedkavé cholestáza
The majority of the patients had AJCC Stage IV disease (93%); 58% had M1c disease at study entry. 
%); 58 % malo ochorenie v štádiu M1c.
Symptomatic Grade 2 or 3 hypothyroidism, hyperthyroidism, hypophysitis, 
Symptomatický hypotyreoidizmus, hypertyreoidizmus, hypofyzitída 2. alebo 3. stupňa nedostatočnosť nadobličiek 2. stupňa, cukrovka 3. stupňa
Resolution occurred in 186 patients (89.4%) with a median time to resolution of 3.0 weeks (range: 0.1-159.4+). 
%) s mediánom času do vyriešenia 3,0 týždne (rozsah: 0,1-159,4+).
Nivolumab monotherapy: 
Monoterapia nivolumabom:
Progression Free Survival Events (%) 
%) nežiaduce reakcie únava (48
In patients treated with nivolumab monotherapy, the incidence of nephritis or renal dysfunction was 2.8% (71/2578). 
U pacientov liečených nivolumabom v monoterapii bola incidencia nefritídy alebo dysfunkcie obličiek 2,8
Hazard ratio 95% CI p-value 
95 % CI p-hodnota p <
Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for any severe immune-related adverse reaction that recurs and for any life-threatening immune-related adverse reaction. 
Z dôvodu akejkoľvek závažnej imunitne podmienenej nežiaducej reakcie, ktorá sa opakovane vyskytne a z dôvodu akejkoľvek život ohrozujúcej imunitne podmienenej nežiaducej reakcie sa liečba nivolumabom alebo nivolumabom v kombinácii s ipilimumabom musí natrvalo ukončiť.
Randomisation was stratified by PD-L1 expression (≥ 5% vs. < 5% tumour cell membrane expression), BRAF status, and M stage per the American Joint Committee on Cancer (AJCC) staging system. 
Štúdia zahŕňala dospelých pacientov, ktorí mali skóre výkonnostného stavu podľa ECOG 0 alebo 1, so štádiom IIIB/C alebo so štádiom IV podľa Amerického spoločného výboru pre rakovinu (AJCC, American Joint
NAME OF THE MEDICINAL PRODUCT OPDIVO 10 mg/mL concentrate for solution for infusion. 
OPDIVO 10 mg/ml infúzny koncentrát.
Withhold dose(s) until symptoms resolve and management with corticosteroids is completec 
Prerušte podávanie dávky (dávok), pokým príznaky neodznejú a nie je ukončená liečba kortikosteroidmic
Inflammation of the kidney, kidney failure (including abrupt loss of kidney function) Pain, chest pain 
Zápal obličiek, zlyhanie obličiek (vrátane náhlej straty funkcie obličiek)
Nivolumab or nivolumab in combination with ipilimumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash. 
Pri vyrážke 3. stupňa sa má liečba nivolumabom alebo nivolumabom v kombinácii s ipilimumabom prerušiť a pri vyrážke 4. stupňa sa má ukončiť.
Resolution occurred in 140 patients (91.5%) with a median time to resolution of 2.4 weeks (range: 0.1-103.1+). 
%) s mediánom času do vyriešenia 2,4 týždňa (rozsah: 0,1-103,1+).
Hazard ratioa 99.1% CI p-valueb,h Median (95% CI) 
% CI p-hodnotab,h Medián (95
Subsequent systemic therapy was received by 31.8%, 44.3%, and 62.2% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively. 
% s nivolumabom v monoterapii a 62,2 % v skupinách s ipilimumabom.
In patients treated with nivolumab monotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 5.2% for anaemia (all Grade 3), 1.0% for thrombocytopaenia, 1.0% for leucopoenia, 10.0% for lymphopaenia, 1.1% for neutropaenia, 2.1% for increased alkaline phosphatase, 2.7% for increased AST, 2.2% for increased ALT, 1.2% for increased total bilirubin, 0.9% for increased creatinine, 3.8% for hyperglycaemia, 1.0% for hypoglycaemia, 3.5% for increased amylase, 7.9% for increased lipase, 6.4% for hyponatraemia, 1.8% for hyperkalaemia, 1.5% for hypokalaemia, 1.2% for hypercalcaemia, 0.7% for hypermagnesaemia, 0.5% for hypomagnesaemia, 0.7% for hypocalcaemia, and 0.1% for hypernatraemia. 
U pacientov liečených nivolumabom v monoterapii bol podiel pacientov, u ktorých došlo k posunu laboratórnych abnormalít do 3. alebo 4. stupňa od východiskového stavu, nasledovný: 5,2 % z dôvodu anémie (všetky 3. stupňa), 1,0 % z dôvodu trombocytopénie, 1,0 % z dôvodu leukopénie, 10,0 % z dôvodu lymfopénie, 1,1
n ipilimumab Median OS (95% CI) 
+ ipilimumab Medián OS (95
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 2.8% for anaemia (all Grade 3), 1.2% for thrombocytopaenia, 0.5% for leucopoenia, 6.7% for lymphopaenia, 0.7% for neutropaenia, 4.3% for increased alkaline phosphatase, 12.4% for increased AST, 15.3% for increased ALT, 1.2% for increased total bilirubin, 2.4% for increased creatinine, 5.3% for hyperglycaemia, 8.7% for increased amylase, 19.5% for increased lipase, 1.2% for hypocalcaemia, 0.2% each for hypernatraemia and hypercalcaemia, 0.5% for hyperkalemia, 0.3% for hypermagnesaemia, 4.8% for hypokalaemia, and 9.5% for hyponatraemia. 
U pacientov liečených nivolumabom v dávke 3 mg/kg v kombinácii s ipilimumabom v dávke 1 mg/kg pri RCC bol podiel pacientov, u ktorých došlo k zhoršeniu laboratórnych abnormalít do 3. alebo 4. stupňa od východiskového stavu nasledovný: 3,0 % z dôvodu anémie (všetky 3. stupňa), 0,7 % z dôvodu trombocytopénie, 0,6 % z dôvodu leukopénie, 5,1
Progression-free survival Rate (95% CI) at 60 months 
Prežívanie bez progresie Miera (95 % CI) po 12 mesiacoch
Overall survivalc Events Hazard ratioa (95% CI) Rate (95% CI) at 24 months Confirmed objective response (95% CI) Median duration of response Months (range) Progression-free survival Rate (95% CI) at 24 months 
Výskyt (95 % CI) po 6 mesiacoch Výskyt (95 % CI) po 12 mesiacoch Potvrdená objektívna odpoveďc (95 %
Nivolumab+Ipilimumab (events: 77/155), median and 95% CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (events: 86/171), median and 95% CI: 14.00 (7.03, N.A.) Ipilimumab (events: 129/164), median and 95% CI: 3.91 (2.83, 4.17) 
Nivolumab+Ipilimumab (udalosti: 77/155), medián a 95 % CI: 12,35 (8,74; N.A.)
Grade 2, Grade 3, and Grade 4 cases were reported in 4.4% (24/547), 0.7% (4/547), and 0.5% (3/547) of patients, respectively. 
% (4/547) a 4. stupňa u 0,5
Figure 11: Kaplan-Meier curves of OS in intermediate/poor risk patients (CA209214) 
OS u pacientov so stredným/s vysokým rizikom (CA209214)
Severe diarrhoea or colitis has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8). 
Pri monoterapii nivolumabom alebo pri nivolumabe v kombinácii s ipilimumabom sa pozorovala závažná hnačka alebo kolitída (pozri časť 4.8).
1 vial 
1. typu)
The Kaplan-Meier curves for OS are shown in Figure 10. 
OS sú uvedené na obrázku 10.
The Kaplan-Meier curves for OS are shown in Figure 12. 
OS sú uvedené na obrázku 12.
Nivolumab treatment resulted in rapid resolution of B-symptoms in 88.7% (47/53) of the patients, with a median time to resolution of 1.9 months. 
Liečba nivolumabom mala za následok rýchle vyriešenie B-symptómov u 88,7
Grade 2, Grade 3, and Grade 4 cases were reported in 0.5% (3/547), 2.4% (13/547), and 0.4% (2/547) of patients, respectively. 
Prípady 2. stupňa sa hlásili u 0,5 % (3/547),
Bristol-Myers Squibb A.E. Τηλ: + 357 800 92666 
Τηλ: + 357 800 92666
The Kaplan-Meier curves for OS are shown in Figure 9. 
OS sú uvedené na obrázku 9.
Resolution occurred in 428 patients (63.8%) with a median time to resolution of 17.1 weeks 
K vyriešeniu došlo u 428 pacientov (63,8
Tumour PD-L1 expression levels were balanced between the two treatment groups (nivolumab vs. investigator's choice) at each of the predefined tumour PD-L1 expression levels of ≥ 1% (55% vs. 62%), ≥ 5% (34% vs. 43%), or ≥ 10% (27% vs. 
Hladiny expresie PD-L1 v nádore boli medzi dvoma liečenými skupinami (nivolumab oproti voľbe skúšajúceho) vyrovnané pri všetkých preddefinovaných hladinách expresie PD-L1 v nádore ≥ 1
Grade 4 rash 
4. stupňa hypertyreoidizmus
For Grade 4 diarrhoea or colitis, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. 
Z dôvodu hnačky alebo kolitídy 4. stupňa sa musí liečba nivolumabom alebo nivolumabom v kombinácii s ipilimumabom natrvalo ukončiť a má sa začať liečba kortikosteroidmi v dávke zodpovedajúcej metylprednizolónu 1 až 2 mg/kg/deň.
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448). 
U pacientov liečených nivolumabom v dávke 1 mg/kg v kombinácii s ipilimumabom v dávke 3 mg/kg pri melanóme bola incidencia nefritídy alebo dysfunkcie obličiek 5,1
The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed ORR and PFS. 
Meranými kľúčovými sekundárnymi koncovými ukazovateľmi účinnosti boli ORR a PFS hodnotené skúšajúcim.
Very common (may affect more than 1 in 10 people) Underactive thyroid gland (which can cause tiredness or weight gain),overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss) Decreased appetite 
Nedostatočná funkcia štítnej žľazy (ktorá môže spôsobiť únavu alebo prírastok telesnej hmotnosti), nadmerná funkcia štítnej žľazy (ktorá môže spôsobiť rýchly tep srdca, potenie a úbytok telesnej hmotnosti)
The majority of cases were Grade 1 or 2 in severity reported in 3.5% (91/2578) and 1.2% (32/2578) of patients respectively. 
% (91/2 578) alebo 2. stupňa u 1,2 % (32/2 578) pacientov.
The observed OS benefit was consistently demonstrated across subgroups of patients including baseline ECOG performance status, M stage, history of brain metastases, and baseline LDH level. 
Prínos RFS bol zhodne preukázaný v podskupinách vrátane expresie PD-L1 v nádore, stavu BRAF a štádia ochorenia.
The primary efficacy population included those intermediate/poor risk patients with at least 1 or more of 6 prognostic risk factors as per the International Metastatic RCC Database Consortium (IMDC) criteria (less than one year from time of initial renal cell carcinoma diagnosis to randomisation, Karnofsky performance status <80%, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, platelet count greater than the upper limit of normal, and absolute neutrophil count greater than the upper limit of normal). 
Populácia s primárnou účinnosťou zahŕňala pacientov so stredným/s vysokým rizikom s minimálne 1 alebo viacerými zo 6 prognostických rizikových faktorov podľa kritérií medzinárodného združenia IMDC (IMDC, International Metastatic RCC
All were considered not related to nivolumab by investigators except arrhythmia (atrial fibrillation, tachycardia and ventricular arrhythmia). 
Okrem arytmií (atriálna fibrilácia, tachykardia a ventrikulárna arytmia) boli všetky nežiaduce udalosti posúdené skúšajúcimi ako nesúvisiace s nivolumabom.
Among the patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in CA209214, 169/547 (31%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase. 
U pacientov liečených nivolumabom v dávke 3 mg/kg v kombinácii s ipilimumabom v dávke 1 mg/kg v štúdii CA209214 malo 169/547 (31
The study included patients (18 years or older) who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen and an ECOG performance status score of 0 or 1. 
Do štúdie boli zaradení pacienti (18 roční alebo starší), ktorí mali progresiu ochorenia počas alebo po jednom predchádzajúcom chemoterapeutickom režime založenom na platinovom
For Grade 4 serum creatinine elevation, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. 
Z dôvodu vzostupu kreatinínu v sére 4. stupňa sa musí liečba nivolumabom alebo nivolumabom v kombinácii s ipilimumabom natrvalo ukončiť a má sa začať liečba kortikosteroidmi v dávke zodpovedajúcej metylprednizolónu 1 až 2 mg/kg/deň.
Resolution occurred in 296 patients (88.1%) with a median time to resolution of 2.1 weeks (range: 0.1-124.4+). 
%) s mediánom času do vyriešenia 2,1 týždňa (rozsah: 0,1 - 124,4+).
Withhold dose(s) 
Stabilizácia ochorenia (SD)
It includes 243 patients who had ASCT; Cohort A included 63 (26%) patients who were brentuximab vedotin naïve; Cohort B included 80 (33%) patients who had received brentuximab vedotin after ASCT failure; and Cohort C included 100 (41%) patients who had received brentuximab vedotin before and/or after ASCT out of which 33 (14%) patients received brentuximab vedotin only prior to ASCT. 
%) pacientov, ktorí sa predtým neliečili brentuximab vedotinom; Kohorta B zahŕňala 80 (33
Nivolumab+Ipilimumab (events: 59/123), median and 95% CI: N.A. (26.45, N.A.) ──Δ─── Nivolumab (events: 71/117), median and 95% CI: 23.46 months (13.01, 36.53) Ipilimumab (events: 77/113), median and 95% CI: 18.56 months (13.67, 23.20) 
Ipilimumab (udalosti: 77/113), medián a 95 % CI: 18,56 mesiacov (13,67; 23,20)
The PFS HRs for nivolumab vs. chemotherapy were 1.58 (95% CI: 0.87, 2.87) for BRAF mutationpositive patients and 0.82 (95% CI: 0.60, 1.12) for BRAF wild-type patients. 
u pacientov s pozitívnou mutáciou BRAF a 0,82 (95 % CI: 0,60; 1,12) u pacientov s divokým typom BRAF.
A total of 272 patients were randomised to receive either nivolumab 3 mg/kg (n = 135) administered intravenously over 60 minutes every 2 weeks or docetaxel (n = 137) 75 mg/m2 every 3 weeks. 
Celkovo bolo randomizovaných 272 pacientov, buď na intravenózne podávanie nivolumabu v dávke 3 mg/kg počas 60 minút každé 2 týždne (n =
Not known pericardial disordersj Vascular disorders Common hypertension hypertension 
Poruchy ciev Časté hypertenzia hypertenzia
Headache 
Vyrážka
Nivolumab monotherapy should be withheld for Grade 3 diarrhoea or colitis, and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. 
Z dôvodu hnačky alebo kolitídy 3. stupňa sa má prerušiť monoterapia nivolumabom a má sa začať liečba kortikosteroidmi v dávke zodpovedajúcej metylprednizolónu 1 až 2 mg/kg/deň.
Grade 2, Grade 3, and Grade 4 cases were reported in 4.7% (21/448), 1.1% (5/448), and 0.2% (1/448) of patients, respectively. 
Prípady 2. stupňa sa hlásili u 4,7 % (21/448),
Grade 2, Grade 3, and Grade 4 cases were reported in 1.6% (7/448), 0.9% (4/448), and 0.7% (3/448) of patients, respectively. 
2. stupňa, 3. stupňa a 4. stupňa sa vyskytla u 1,6 % (7/448), 1,3
The improvement in OS was similar between nivolumab in combination with ipilimumab and nivolumab monotherapy in patients with high tumour PD-L1 expression (PD-L1 ≥ 1%). 
Pri nivolumabe v kombinácii s ipilimumabom pri expresii PD-L1 v nádore ≥ 1
OPDIVO infusion 
Zatvorená injekčná liekovka
Among all randomised patients, the ORR was 27.2% (95% CI: 22.0, 32.9) in the nivolumab group and 9.8% (95% CI: 5.3, 16.1) in the chemotherapy group. 
% (95 % CI: 22,0; 32,9) a v skupine s chemoterapiou 9,8
Common hypothyroidism, hyperthyroidism 
Menej časté dehydratácia, metabolická acidóza
In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of diarrhoea or colitis was 28.2% (154/547). 
U pacientov liečených nivolumabom v dávke 3 mg/kg v kombinácii s ipilimumabom v dávke 1 mg/kg pri RCC bola incidencia hnačky alebo kolitídy 28,2
Range 
Randomizovaná
Bristol-Myers Squibb A.E. Τηλ: + 30 210 6074300 
Τηλ: + 30 210 6074300
Objective response, n (%); (95% CI) Complete remission (CR), n (%); (95% CI) Partial remission (PR), n (%); (95% CI) 
Čiastočná remisia (PR), n (%);
OPDIVO in combination with ipilimumab Melanoma 
OPDIVO v kombinácii s ipilimumabom
Events Hazard ratio 95% CI Rate (95% CI) at 60 months 
Udalosti Pomer rizika 95 % CI Výskyt (95 % CI) pri 24 mesiacoch
OPDIVO concentrate may be diluted with either: sodium chloride 9 mg/mL (0.9%) solution for injection; or 50 mg/mL (5%) glucose solution for injection. 
% (9 mg/ml) injekčným roztokom chloridu sodného; alebo 5 % (50 mg/ml) injekčným roztokom glukózy.
Median OS for tumour PD-L1 expression ≥ 1% was not reached for nivolumab in combination with ipilimumab, and was 19.61 months in the sunitinib arm (HR = 0.52; 95% CI: 0.34, 0.78). 
% sa nedosiahol medián OS a v skupine so sunitinibom bol 19,61 mesiaca (HR =
In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of rash was 48.8% (267/547). 
U pacientov liečených nivolumabom v dávke 3 mg/kg v kombinácii s ipilimumabom v dávke 1 mg/kg pri RCC bola incidencia vyrážky 48,8
Inflammation of the eye (which causes pain and redness), blurred vision Fast heart rate 
Zápal nervov (spôsobujúci znecitlivenie, oslabenie, rezavú alebo pálivú bolesť rúk a nôh), závrat Zápal oka (ktorý môže spôsobiť bolesť alebo sčervenenie), rozmazané videnie Rýchly tep srdca
When nivolumab 3 mg/kg was administered in combination with ipilimumab 1 mg/kg, the CL of nivolumab was increased by 1% and the CL of ipilimumab was decreased by 1.5%, which were not considered clinically relevant. 
Ak sa nivolumab v dávke 3 mg/kg podával v kombinácii s ipilimumabom v dávke 1 mg/kg, CL nivolumabu sa zvýšil o 1
nivolumab (n = 453) 
Výsledky účinnosti (CA209238) nivolumab (n = 453)
Objective response (95% CI) Odds ratio (95% CI) p-value 
Celkové prežívanie Udalosti Pomer rizikaa (95 % CI) p-hodnotab Medián (95
Baseline characteristics were balanced between groups except for the proportions of patients who had a history of brain metastasis (19% and 13% in the nivolumab group and chemotherapy group, respectively) and patients with LDH greater than ULN at baseline (51% and 35%, respectively). 
Základnou charakteristikou bola rovnováha medzi skupinami s výnimkou počtov pacientov, ktorí mali metastázy v mozgu v anamnéze (19
≥ 1% to < 10%a ≥ 10% to < 50%a ≥ 50%a 
%, 5 % a 10
Grade 2, Grade 3, and Grade 4 cases were reported in 13.6% (61/448), 15.8% (71/448), and 0.4% (2/448) of patients, respectively. 
Prípady 2. stupňa sa hlásili u 13,6 % (61/448),
Grade 2, Grade 3, and Grade 4 cases were reported in 4.8% (26/547), 6.6% (36/547), and 1.6% (9/547) of patients, respectively. 
% (26/547), 3. stupňa u 6,6 % (36/547)
- Adjuvant treatment of melanoma (monotherapy): study 
Toto bude poskytnuté pre schválené indikácie: - Adjuvantná liečba melanómu (monoterapia): štúdia CA209238
240 mg every 2 weeks over 30 minutes *As per monotherapy indication in section 4.1. 
240) počas 60 minút každé 2 týždne alebo podľa voľby skúšajúceho buď na cetuximab (n =
The co-primary outcome measures were progression-free survival and OS. ORR and the duration of response were also assessed. 
Merané súbežné primárne koncové ukazovatele boli prežívanie bez progresie a OS.
Nivolumab+Ipilimumab (events: 29/68), median and 95% CI: N.A. (9.72, N.A.) ──Δ─── Nivolumab (events: 38/80), median and 95% CI: 21.95 (8.90, N.A.) Ipilimumab (events: 57/75), median and 95% CI: 3.94 (2.79, 4.21) 
Ipilimumab (udalosti: 57/75), medián a 95 % CI: 3,94 (2,79; 4,21)
Table 25: Efficacy by tumour cell and TAIC PD-L1 expression (CA209141) 
Účinnosť pomocou expresie PD-L1 v nádorových bunkách a v TAIC
Nivolumab+Ipilimumab (events: 111/210), median and 95% CI: 11.10 (7.98, 22.18) ──Δ─── Nivolumab (events: 125/208), median and 95% CI: 5.32 (2.83, 7.06) Ipilimumab (events: 159/202), median and 95% CI: 2.83 (2.76, 3.09) 
Ipilimumab (udalosti: 159/202), medián a 95 % CI: 2,83 (2,76; 3,09)
Further information on Chanhold can be found on the Agency's website: ema.europa.eu/Find medicines/veterinary/EPAR/chanhold. 
Chanhold sa nachádzajú na webovej stránke agentúry: ema.europa.eu/Find medicines/veterinary/EPAR/chanhold.
Chanhold received a marketing authorisation valid throughout the EU on 17 April 2019. 
Chanhold bolo dňa 17/04/2019 udelené povolenie na uvedenie na trh platné v celej EÚ.
This small volume of liquid is absorbed through the skin and has an effect throughout the animal's body. 
Toto malé množstvo tekutiny sa vstrebe do kože a účinkuje v celom tele zvieraťa.
The medicine is available as a spot-on solution in 2 different concentrations (6% and 12%) and in tubes of various strengths (15, 30, 45, 60, 120, 240 and 360 mg). 
%) v tubách v rôznych silách (15, 30, 45, 60, 120, 240 a 360 mg).
An overview of Chanhold and why it is authorised in the EU 
Prehľad o lieku Chanhold a prečo bol povolený v EÚ
The strength used and the number of administrations depend on the weight and species of the animal being treated, and the type of parasite. 
Použitá sila a počet aplikácií závisia od hmotnosti a druhu liečeného zvieraťa a druhu parazita.
The package leaflet contains detailed information on dosage and duration of treatment. 
V písomnej informácii pre používateľa sa nachádzajú podrobné informácie o dávkovaní a trvaní liečby.
This means that Chanhold contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Stronghold. 
To znamená, že liek Chanhold obsahuje rovnaké liečivo a pôsobí rovnakým spôsobom ako tzv. referenčný liek, ktorý je už v Európskej únii (EÚ) povolený pod názvom Stronghold.
The European Medicines Agency concluded that, in accordance with EU requirements, Chanhold has been shown to be comparable to Stronghold. 
Európska agentúra pre lieky dospela k záveru, že v súlade s požiadavkami EÚ sa preukázalo, že liek Chanhold je porovnateľný s liekom Stronghold.
There was no need for ‘bioequivalence' studies to investigate whether Chanhold is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. 
Nebolo potrebné vykonať tzv. štúdie biologickej rovnocennosti na preskúmanie toho, či sa liek Chanhold vstrebáva podobne ako referenčný liek, aby vytváral rovnaké hladiny liečiva v krvi.
Why is Chanhold authorised in the EU? 
Chanhold povolený v EÚ?