FDA Label for Bortezomib
View Indications, Usage & Precautions
Bortezomib Product Label
The following document was submitted to the FDA by the labeler of this product Zydus Lifesciences Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package Label.Principal Display Panel
NDC 70771-1708-1
Bortezomib for Injection
3.5 mg/vial
For Intravenous or Subcutaneous Use
One Single-dose Vial
Rx only
NDC 70771-1708-1
Bortezomib for Injection – Carton label
3.5 mg/vial
For Intravenous or Subcutaneous Use
Reconstitution Information
SUBCUTANEOUS INJECTION ONLY
0.9% NaCl
Add
1.4 mL
0.9% Sodium Chloride
To make
2.5 mg/mL
final concentration
INTRAVENOUS INJECTION ONLY
0.9% NaCl
Add
3.5 mL
0.9% Sodium Chloride
To make
1 mg/mL
final concentration
One Single-dose Vial
Rx only
Reconstitution Information – Inside Flap (All cartons)
SUBCUTANEOUS INJECTION ONLY
0.9% NaCl
Add
1.4 mL
0.9% Sodium Chloride
To make
2.5 mg/mL
final concentration
INTRAVENOUS INJECTION ONLY
0.9% NaCl
Add
3.5 mL
0.9% Sodium Chloride
To make
1 mg/mL
final concentration
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