Sterile water for inhalation

Comments the USP 28 (Suppl. 1.0) describes sterile water for inhalation as water purified by distillation or by reverse osmosis and rendered sterile. It contains no antimicrobial agents or other added substances, except where used in humidifiers or other similar devices, and where liable to contamination over a period of time. 

Reconstitution - Reconstitute drug with a minimum of 75 mL sterile water for injection or inhalation in the original 100 mL vial. Shake well. Transfer to the clean, sterilized 500 mL SPAG-2 reservoir and further dilute to a final volume of 300 mL with sterile water for injection or inhalation. The final concentration should be 20 mg/mL. 

Virazole is a brand name for ribavirin, a synthetic nucleoside with antiviral activity. VIRAZOLE for inhalation solution is a sterile, lyophilized powder to be reconstituted for aerosol administration. Each 100-mL glass vial contains 6 g ribavirin, and when reconstituted to the recommended volume of 300 mL with sterile water for injection... 

Sterile water for drug products and pharmaceutical preparations not suitable for use in the manufacture of parenteral products. Diluent for inhalation therapy products. 

In cases of severe acute asthmatic attacks, bronchodilators and steroids for direct dehveiy to the lungs may be needed in large doses. This is achieved by direct inhalation via a nebulizer device this converts a liquid into a mist or fine spray. The dmg is diluted in small volumes of Water for Injections BP before loading into the reservoir of the machine. This vehicle must be sterile and preservative-fiee and is therefore prepared as a terminally sterilized unit dose in polyethylene nebules. 

Pot inhalation treatment of respiratory diseases a pharmaceutical DNase I aerosol Is on the market Pulmozyme is a sterile solution for respiratory use at a concentration of 1000 Genentech UnitafaiL [22]. It contains 1 mg/mL rhDNasc, sodium chloride as a tonicity modifier, calcium chloride as a stabilizer, and water for injection. Since deamidation is mnid at hirit nH and anaenation ncoin at low... 

For inhalation treatment of respiratory diseases, a pharmaceutical DNase I aerosol is on the market. Pulmozyme is a sterile solution for respiratory use at a concentration of 1000 Genentech Units/mL [22]. It contains 1 mg/mL rhDNase, sodium chloride as a tonicity modifier, calcium chloride as a stabilizer, and water for injection. Since deamidation is rapid at high pH and aggregation occurs at low pH, a nearly neutral solution (pH 6.3) is required. It is administered by means of a compressed air-driven nebulizer. Each 2.5-mL single-unit ampule will deliver 2.5 mg of rhDNase to the nebulizer chamber. The efficacy of DNase inhalation therapy largely depends on the aerosol quality and characteristics, which determine the respirable fraction. Significant differences were found between the different aerosol drug-delivery systems [68,81]. 

PPARa -/- and PPARa+/+ mice used for this study have been described. For the metabolic inhibitor studies, etomoxir (50 ig/gbody mass) or vehicle (sterile water) was given as a daily intraperitoneal injection at 09 00 a.m. for five days. At the time of harvest, animals were killed by CO2 inhalation and liver and cardiac ventricle were rapidly dissected free, snap-frozen in liquid nitrogen, and stored at -80 X until processed for isolation of RNA or lipid extraction. For histologic analyses, the tissue was processed at the time of harvest as described below. 

Injectable products, ophthalmic products, and inhalation solutions Pharmaceutical ingredients Purified water Manufacturing environment Products As above Loop and taps daily Every shift in critical aseptic processing areas Every batch with the exception of terminally sterilized products approved for parametric release... 

Because terrorist-caused bomlism would most likely be food-borne or inhala-tional, acceptable specimens include feces, gastric aspirate/vomitus, serum, suspected food, and environmental samples (37). Feces, gastric aspirates, or vomitus may be helpful for detecting both food-borne and inhalational botulinum toxin. A walnut-sized, 10-50 g stool sample, placed in a sterile, unbreakable, carefully labeled container, should be sufficient. Enemas are an acceptable alternative for constipated patients. To avoid diluting the toxin and confounding the mouse bioassay, a minimal amount of sterile, nonbacteriostatic water should be used. A 20 ml sample, placed in a sterile, unbreakable, carefully labeled container, should be sufficient. Similarly, 20 ml of gastric aspirate and vomitus, placed in the same type of container, is appropriate. 

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