RIBAVIRIN powder, for solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Ribavirin (UNII: 49717AWG6K) (Ribavirin - UNII:49717AWG6K)

可用日期:

Cameron Pharmaceuticals

给药途径:

RESPIRATORY (INHALATION)

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Ribavirin for Inhalation Solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. 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 cardiopulmonar

產品總結:

Ribavirin for Inhalation Solution, USP is supplied in a one-pack count containing 100 mL glass vial with 6 grams of Sterile, lyophilized drug which is to be reconstituted with 300 mL Sterile Water for Injection, USP or Sterile Water for Inhalation (no preservatives added) and administered only by a small particle aerosol generator (SPAG® -2). NDC 42494-423-01 One 6 g glass vial Vials containing the lyophilized drug powder should be stored in a dry place at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Reconstituted solutions may be stored, under sterile conditions, at room temperature 20° to 30°C (68° to 86°F) for 24 hours. Solutions which have been placed in the SPAG-2 unit should be discarded at least every 24 hours.

授权状态:

New Drug Application

产品特点

RIBAVIRIN- RIBAVIRIN POWDER, FOR SOLUTION
CAMERON PHARMACEUTICALS
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RIBAVIRIN FOR INHALATION SOLUTION, USP
WARNINGS
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
THE SPECIFIC VENTILATOR BEING USED AND THIS MODE OF
ADMINISTRATION OF THE DRUG. STRICT ATTENTION MUST BE PAID TO
PROCEDURES THAT HAVE BEEN SHOWN TO MINIMIZE THE ACCUMULATION
OF DRUG PRECIPITATE, WHICH CAN RESULT IN MECHANICAL VENTILATOR
DYSFUNCTION AND ASSOCIATED INCREASED PULMONARY PRESSURES (SEE
WARNINGS).
SUDDEN DETERIORATION OF RESPIRATORY FUNCTION HAS BEEN
ASSOCIATED WITH INITIATION OF AEROSOLIZED RIBAVIRIN FOR
INHALATION SOLUTION, USP USE IN INFANTS. RESPIRATORY FUNCTION
SHOULD BE CAREFULLY MONITORED DURING TREATMENT. IF INITIATION OF
AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP TREATMENT
APPEARS TO PRODUCE SUDDEN DETERIORATION OF RESPIRATORY
FUNCTION, TREATMENT SHOULD BE STOPPED AND REINSTITUTED ONLY
WITH EXTREME CAUTION, CONTINUOUS MONITORING AND CONSIDERATION
OF CONCOMITANT ADMINISTRATION OF BRONCHODILATORS (SEE
WARNINGS).
RIBAVIRIN FOR INHALATION SOLUTION, USP IS NOT INDICATED FOR USE IN
ADULTS. PHYSICIANS AND PATIENTS SHOULD BE AWARE THAT RIBAVIRIN
HAS BEEN SHOWN TO PRODUCE TESTICULAR LESIONS IN RODENTS AND TO
BE TERATOGENIC IN ALL ANIMAL SPECIES IN WHICH ADEQUATE STUDIES
HAVE BEEN CONDUCTED (RODENTS AND RABBITS) (SEE
CONTRAINDICATIONS).
DESCRIPTION
Ribavirin is a synthetic nucleoside with antiviral activity. Ribavirin
for inhalation solution, USP is a
sterile, lyophilized powder to be reconstituted for aerosol
administration. Each 100 mL glass vial
contains 6 grams of ribavirin, and when reconstituted to the
recommended volume of 300 mL with
Sterile Water for Injection, USP or Sterile Water for Inhalation (no
preservatives added), will contain
20 mg of ribavirin per mL, pH approximately 5.5. Aerosolization is to
be carried out in a Small Particle
Aerosol Generator (SPAG -2) nebulizer only.
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