Product Details

Ribavirin for Inhalation Solution, USP

Pronunciation: rye-bah-VYE-rin

Strength:
6gm
NDC-9:
68382-0395
Dosage Form:
Vial
TE Code:
AN
Reference Listed Drug:
Virazole®
Shape:
Glass vial, 4 vials per carton
Color:
Imprint Code:
Therapeutic Category:
Antiviral
Product Status:
Active
Ribavirin for Inhalation Solution, USP

* NOT TO SCALE

Indications

Ribavirin for inhalation solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy.

Only severe RSV lower respiratory tract infection should be treated with ribavirin for inhalation solution, USP. The vast majority of infants and children with RSV infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. Many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of ribavirin for inhalation solution, USP aerosol (3 to 7 days) and should not be treated with the drug. Thus the decision to treat with ribavirin for inhalation solution, USP should be based on the severity of the RSV infection. The presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonary disease may increase the severity of clinical manifestations and complications of RSV infection.

Use of aerosolized ribavirin for inhalation solution, USP in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with this mode of administration and the specific ventilator being used (see WARNINGS, and DOSAGE AND ADMINISTRATION).

Special Instructions

Keep this product, and all medications, out of the reach of children. Vials containing the lyophilized drug powder should be stored in a dry place at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F). Reconstituted solutions may be stored, under sterile conditions, at room temperature (20-30°C, 68-86°F) for 24 hours. Solutions which have been placed in the SPAG-2 unit should be discarded at least every 24 hours.

Allergen Information

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Case Information

Bottle of 100mL  
NDC:68382-0395-04  
UPC:368382395047  
Case Qty:12  
Case Dimensions (LxWxH - inches):9.2 x 13.4 x 9.6  
Case Weight:11.00  
Bottle Dimensions (WxH - inches):N/A  
Bottle Size:  
Product Shelf Life (months):24