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ropivacaine hydrochloride injection, USP How Supplied/Storage and Handling

HOW SUPPLIED

Ropivacaine Hydrochloride Injection, USP is a clear, colorless solution supplied in single-dose vials in packages of 10 vials per carton as follows:

Unit of Sale

Concentration

NDC 0409-9300-10

Carton of 10 Single-dose Vials

20 mg/10 mL

(2 mg/mL) (0.2%)

NDC 0409-9300-20

Carton of 10 Single-dose Vials

40 mg/20 mL

(2 mg/mL) (0.2%)

NDC 0409-9301-30

Carton of 10 Single-dose Vials

150 mg/30 mL

(5 mg/mL) (0.5%)

NDC 0409-9302-20

Carton of 10 Single-dose Vials

150 mg/20 mL

(7.5 mg/mL) (0.75%)

NDC 0409-9303-10

Carton of 10 Single-dose Vials

100 mg/10 mL

(10 mg/mL) (1%)

NDC 0409-9303-20

Carton of 10 Single-dose Vials

200 mg/20 mL

(10 mg/mL) (1%)

The solubility of ropivacaine is limited at pH above 6. Thus, care must be taken as precipitation may occur if ropivacaine is mixed with alkaline solutions.

Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema.

When chemical disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. It is recommended that chemical disinfection be accomplished by wiping the vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use. When a container is required to have a sterile outside, glass containers may, as an alternative, be autoclaved once. Stability has been demonstrated using a targeted F0 of 7 minutes at 121°C.

Solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

These products are intended for single dose and are free from preservatives. Any solution remaining from an opened container should be discarded promptly.

Distributed by, Hospira, Inc., Lake Forest, IL 60045 USA
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LAB-1390-1.0

Revised: 1/2020

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