Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Ipilimumab 5 mg/mL;
Bristol-Myers Squibb (NZ) Limited
Ipilimumab 5 mg/mL
200 mg/40 mL
Concentrate for injection
Active: Ipilimumab 5 mg/mL Excipient: Hydrochloric acid Mannitol Nitrogen Pentetic acid Polysorbate 80 Sodium chloride Sodium hydroxide Trometamol hydrochloride Water for injection
Vial, glass, 40 mL
Prescription
Prescription
Bristol-Myers Squibb Co CPO
YERVOY, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. YERVOY, in combination with OPDIVO (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic disease melanoma.
Package - Contents - Shelf Life: Vial, glass, - 40 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours opened stored at or below 25°C. before or after dilution to 1 - 4 mg/mL
2011-09-07
YERVOY ® CMI V9.0 1 YERVOY® (YURE-VOY) _Ipilimumab (ipi-lim-u-mab) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about YERVOY. 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 YERVOY 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 YERVOY USED FOR YERVOY contains the active substance ipilimumab, a protein which helps your immune system to attack and destroy cancer cells. _TREATMENT WITH YERVOY _ YERVOY, as a single therapy is used to treat skin cancer (unresectable or advanced melanoma) in adults. _TREATMENT WITH YERVOY IN _ _COMBINATION WITH NIVOLUMAB _ YERVOY in combination with nivolumab is used to treat advanced skin cancer (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 YERVOY IN _ _COMBINATION WITH NIVOLUMAB _ _AND CHEMOTHERAPY _ YERVOY in combination with nivolumab and chemotherapy is used to treat advanced lung cancer in adults. This medicine is available only with a doctor's prescription. YERVOY will be given to you in hospital under the supervision of an experienced doctor. Ask your doctor if you have any questions about why YERVOY has been prescribed for you. BEFORE YOU ARE GIVEN YERVOY _YOU SHOULD NOT BE GIVEN _ _YERVOY _ • if you are allergic (hypersensitive) to ipilimumab or any of the other ingredients of YERVOY. If you are not sure, talk to your doctor. CHECK WITH YOUR DOCTOR OR NURSE BEFORE YOU ARE GIVEN YERVOY • if you take corticosteroids or immunosuppressive therapy. These are medicines which reduce the functioning of your immune system, and may make you Pročitajte cijeli dokument
YERVOY Data Sheet V19.0 1 DATA SHEET 1. PRODUCT NAME YERVOY ® (ipilimumab) 5mg per 1mL concentrate solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of concentrate contains 5 mg ipilimumab. One 10 mL vial contains 50 mg of ipilimumab. One 40 mL vial contains 200 mg of ipilimumab. CAS: 477202-00-9. YERVOY (ipilimumab (rch)) is a recombinant, fully human monoclonal antibody that binds to the cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). Ipilimumab is an IgG1 kappa immunoglobulin with an approximate molecular weight of 148 kDa. Ipilimumab is produced in mammalian (Chinese hamster ovary) cell culture. EXCIPIENT WITH KNOWN EFFECT Each ml of concentrate contains 0.1 mmol sodium, which is 2.30 mg sodium. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). YERVOY is a sterile, preservative free liquid for intravenous (IV) administration, which may contain a small amount of visible translucent-to-white, amorphous ipilimumab particulates. YERVOY has a pH of 7.0 and an osmolarity of 260-300mOsm/kg. It is supplied at a nominal concentration of 5 mg/mL ipilimumab in 50-mg and 200-mg single-use vials. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS _MELANOMA _ YERVOY, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. YERVOY, in combination with nivolumab, 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. _RENAL CELL CARCINOMA (RCC) _ YERVOY, in combination with nivolumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma. _NON-SMALL CELL LUNG CANCER (NSCLC) _ YERVOY, in combination with nivolumab an Pročitajte cijeli dokument