Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Nivolumab 10 mg/mL; ; ;
Bristol-Myers Squibb (NZ) Limited
Nivolumab 47 mg (= 40mg/4 mL)
40 mg/4mL
Concentrate for infusion
Active: Nivolumab 10 mg/mL Excipient: Hydrochloric acid Mannitol Pentetic acid Polysorbate 80 Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water for injection
Prescription
Lonza Biologics Inc
OPDIVO, as monotherapy is indicated for the treatment of patients with unresectable or metastatic melanoma. OPDIVO, in combination with YERVOY (ipilimumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. OPDIVO, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
Package - Contents - Shelf Life: Vial, glass, Type 1 clear. Closure: film coated butyl rubber stopper + al crimp seal - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours not refrigerated stored at or below 25°C 7 days diluted stored at 2° to 8°C (Refrigerate, do not freeze). Product can be stored unrefrigerated (at or below 25 deg C) for up to 8 hours in this 7 day period
2016-01-14
OPDIVO CMI_V15.0 OPDIVO ® (OP-DEE-VOH) _Nivolumab (nee-vol-u-mab) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OPDIVO. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you receiving OPDIVO against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR. YOU SHOULD READ THIS LEAFLET CAREFULLY AND KEEP IT IN A SAFE PLACE TO REFER TO IT LATER. WHAT IS OPDIVO USED FOR OPDIVO contains the active substance nivolumab, a protein which helps your immune system to attack and destroy cancer cells. _TREATMENT WITH OPDIVO_ OPDIVO is used to treat advanced melanoma (unresectable or metastatic). OPDIVO is also used to treat skin cancer (melanoma) after surgical removal of the cancer. OPDIVO is used to treat a type of lung cancer (advanced squamous and non squamous non-small cell lung cancer), a type of kidney cancer (clear cell renal cell carcinoma) and a type of head and neck cancer (squamous cell cancer of the head and neck), a type of blood cancer called classical Hodgkin lymphoma, a type of bladder cancer (urothelial carcinoma) and a type of liver cancer (hepatocellular carcinoma) and a type of food pipe cancer (oesophageal cancer), if your cancer has not responded, or if it has stopped responding, to earlier treatment. OPDIVO may be used after chemoradiotherapy followed by surgical removal of cancer in your oesophagus (food pipe) or gastro- oesophageal junction (area which connects your food pipe and stomach). _TREATMENT WITH OPDIVO IN _ _COMBINATION WITH IPILIMUMAB_ OPDIVO in combination with ipilimumab is used to treat advanced melanoma, (unresectable or metastatic melanoma) a type of advanced kidney cancer (renal cell carcinoma) and malignant pleural mesothelioma (a type of cancer that affects the lining of the lung). _TREATMENT WITH OPDIVO IN _ _COMBINAT Baca dokumen lengkapnya
OPDIVO V29.0 1 DATA SHEET 1 PRODUCT NAME OPDIVO 10 mg/mL concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of concentrate contains 10 mg of nivolumab. Each 40 mg/4mL vial contains 40 mg of nivolumab in 4mL of solution. Each 100 mg/10mL vial contains 100 mg of nivolumab in 10mL of solution. OPDIVO (nivolumab (rch)) is a fully human anti-PD-1 monoclonal antibody (IgG4) produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology. _Excipient with known effect _ Each 1 mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear to opalescent, colorless to pale yellow liquid that may contain few light particles. The solution has a pH of approximately 6.0 and an osmolarity of approximately 340 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MELANOMA OPDIVO, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. OPDIVO, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma. OPDIVO, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. The approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. All analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive. NON-SMALL CELL LUNG CANCER (NSCLC) OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations. OPDIVO, as monotherapy, is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy. Baca dokumen lengkapnya