Nchi: Umoja wa Ulaya
Lugha: Kislovenia
Chanzo: EMA (European Medicines Agency)
nivolumab
Bristol-Myers Squibb Pharma EEIG
L01FF01
nivolumab
Antineoplastična sredstva
Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms
MelanomaOpdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. Relative to nivolumab monotherapy, an increase in progression free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression. Adjuvant treatment of melanomaOpdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Non-small cell lung cancer (NSCLC)Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Neoadjuvant treatment of NSCLCOPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%. Malignant pleural mesothelioma (MPM)Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Neoadjuvant treatment of NSCLCOPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%. Renal cell carcinoma (RCC)Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. Classical Hodgkin lymphoma (cHL)Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Squamous cell cancer of the head and neck (SCCHN)Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. Urothelial carcinomaOpdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. Adjuvant treatment of urothelial carcinomaOPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. Oesophageal squamous cell carcinoma (OSCC)OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. Adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (OC or GEJC)Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. Gastric, gastro‑oesophageal junction (GEJ) or oesophageal adenocarcinomaOPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with HER2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.
Revision: 56
Pooblaščeni
2015-06-19
135 _ _ 7. DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA 8. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP 9. POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku. Ne zamrzujte. Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo. 10. POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI 11. IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Irska 12. ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1014/001 40 mg viala EU/1/15/1014/002 100 mg viala EU/1/15/1014/003 240 mg viala EU/1/15/1014/004 120 mg viala 13. ŠTEVILKA SERIJE Lot 14. NAČIN IZDAJANJA ZDRAVILA 15. NAVODILA ZA UPORABO 16. PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna. 136 _ _ 17. EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _ Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako. 18. EDINSTVENA OZNAKA – V BERLJIVI OBLIKI PC SN NN 137 _ _ PODATKI NA PRIMARNI OVOJNINI NALEPKA VIALE 1. IME ZDRAVILA OPDIVO 10 mg/ml sterilni koncentrat nivolumab 2. NAVEDBA ENE ALI VEČ UČINKOVIN En ml koncentrata vsebuje 10 mg nivolumaba. Ena viala z 12 ml vsebuje 120 mg nivolumaba. Ena viala s 24 ml vsebuje 240 mg nivolumaba. 3. SEZNAM POMOŽNIH SNOVI Pomožne snovi: natrijev citrat dihidrat, natrijev klorid, manitol (E421), pentetska kislina, polisorbat 80 (E433), natrijev hidroksid, klorovodikova kislina in voda za injekcije. 4. FARMACEVTSKA OBLIKA IN VSEBINA sterilni koncentrat 120 mg/12 ml 240 mg/24 ml 5. POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo! i.v. uporaba Samo za enkratno uporabo. 6. POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom! 7. DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA 8. DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP 138 _ _ 9. POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku. Ne zamrzujte. Shranjujte v originaln Soma hati kamili
1 _ _ PRILOGA I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA 2 _ _ 1. IME ZDRAVILA OPDIVO 10 mg/ml koncentrat za raztopino za infundiranje 2. KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml koncentrata za raztopino za infundiranje vsebuje 10 mg nivolumaba. Ena viala s 4 ml vsebuje 40 mg nivolumaba. Ena viala z 10 ml vsebuje 100 mg nivolumaba. Ena viala z 12 ml vsebuje 120 mg nivolumaba. Ena viala s 24 ml vsebuje 240 mg nivolumaba. Nivolumab je pridobljen s tehnologijo rekombinantne DNA na ovarijskih celicah kitajskega hrčka. Pomožna snov z znanim učinkom En ml koncentrata vsebuje 0,1 mmol (ali 2,5 mg) natrija. Za celoten seznam pomožnih snovi glejte poglavje 6.1. 3. FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra do opalescentna, brezbarvna do svetlorumena tekočina, ki lahko vsebuje nekaj svetlih delcev. pH vrednost raztopine je približno 6,0, osmolalnost pa približno 340 mOsm/kg. 4. KLINIČNI PODATKI 4.1 TERAPEVTSKE INDIKACIJE Melanom Zdravilo OPDIVO je v monoterapiji ali v kombinaciji z ipilimumabom indicirano za zdravljenje napredovalega (neoperabilnega ali metastatskega) melanoma pri odraslih in mladostnikih, starih 12 let in starejših. V primerjavi z zdravljenjem z nivolumabom v monoterapiji so pri zdravljenju z nivolumabom v kombinaciji z ipilimumabom podaljšanje preživetja brez napredovanja bolezni (PFS - progression-free survival) in celokupnega preživetja (OS - overall survival) ugotovili le pri bolnikih z nizko ekspresijo PD-L1 tumorja (glejte poglavji 4.4 in 5.1). Adjuvantno zdravljenje melanoma Zdravilo OPDIVO je v monoterapiji indicirano za adjuvantno zdravljenje odraslih in mladostnikov, starih 12 let in starejših, z melanomom v stadiju IIB ali IIC ali melanomom, ki se je razširil na bezgavke, ali z metastatsko boleznijo po popolni kirurški odstranitvi (glejte poglavje 5.1). Nedrobnocelični pljučni rak (NSCLC - non-small cell lung cancer) Zdravilo OPDIVO je v kombinaciji z ipilimumabom in 2 cikloma kemoterapije na osnovi platine indicirano za prvo linijo zd Soma hati kamili