Byooviz (Page 6 of 6)
16 HOW SUPPLIED/STORAGE AND HANDLING
Each BYOOVIZ 0.5 mg carton (NDC 64406-019-01) contains a single-dose, 2-mL glass vial designed to deliver 0.05 mL of 10 mg/mL ranibizumab-nuna solution that is clear to slightly opalescent and colorless to pale yellow.
EACH CARTON IS FOR SINGLE-EYE USE ONLY.
BYOOVIZ should be refrigerated at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Do not use beyond the date stamped on the label. Protect BYOOVIZ vials from light and store in the original carton until time of use.
17 PATIENT COUNSELING INFORMATION
Advise patients that in the days following BYOOVIZ administration, patients are at risk of developing endophthalmitis. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise the patient to seek immediate care from an ophthalmologist [see Warnings and Precautions (5.1) ].
Samsung Bioepis Co., Ltd.
Yeonsu-gu, Incheon, 21987
Republic of Korea
US License No. 2046
225 Binney Street, Cambridge
MA, 02142United States
BYOOVIZ is a trademark of Biogen Inc.
PRINCIPAL DISPLAY PANEL — 0.5 mg Vial Carton
Byooviz™ 0.5mg wAMD RVO mCNO
0.5 mg single-dose vial.
Discard unused portion.
A 5-micron sterile ﬁlter needle (19-gauge x 1-1/2 inch) is required for preparation, but not included.
See enclosed package insert.
For intravitreal injection.
Neovascular (wet) age-related macular degeneration (AMD)
Macular edema following retinal vein occlusion (RVO)
Myopic choroidal neovascularization (mCNV)
DO NOT FREEZE.
PROTECT VIAL FROM LIGHT.
SAMSUNG BIOEPIS, Biogen®
|BYOOVIZ ranibizumab-nuna injection, solution|
|Labeler — BIOGEN INC. (121376230)|
|Registrant — Samsung Bioepis Co., Ltd. (557822226)|
Revised: 09/2022 BIOGEN INC.
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