Multidose vials, parenteral

A parenteral product in a multidose vial must contain a preservative to protect the contents of the vial against contamination during repeated withdrawal of dose aliquots. 

Another important component of most vaccine formulations is a suitable preservative. The three most commonly used preservatives in available vaccines are phenol, 2-phenoxyethanol, and ethyl mercurithiosalicylate (thimerosal). Thimerosal, in particular, is used in multidose vials as an antimicrobial preservative. Concerns about the presence of mercury in thimerosal (25 pg/dose) has led to FDA stopping the use of this preservative in all vaccines by an amendment to the FDA Modernization Act of 1997. By 2001, thimerosal was removed from most childhood vaccines as a precautionary measure. The sources of all of the preservatives for vaccines are the same suppliers that supply preservatives for the parenteral dosage forms (J. T. Baker, Aldrich, Spectrum, etc. from U.S.A.). Table 2 lists some of the preservative concentrations in common vaccines. 

TaxoP is commercially available in 30 mg (5 mL) and 100 mg (16.7 mL) multidose vials. This parenteral concentrate is intended for dilution with a suitable parenteral dilution media before... 

Benzyl alcohol is a preservative that may be present in multidose vials of bacteriostatic sodium chloride and bacteriostatic water for injection and pharmaceuticals available in multidose vials for parenteral use. An association between the presence of benzyl alcohol in solutions used for flushing intravascular catheters and to reconstitute medications and a gasping syndrome and deaths in neonates was first reported in the early 1980s.The neonates also displayed clinical findings such as an elevated anion gap, metabolic acidosis, CNS depression, seizures, respiratory failure, renal and hepatic failures, cardiovascular collapse, and death. Those at highest risk were premature infants who weighted less... 

A. Parenteral. Labetalol hydrochloride (Normodyne, Trandate), 5 mg/mL, 20-mL ampules, 40- and 60-mL multidose vials (with EDTA and parabens as preservative). 

A. Parenteral. Ondansetron hydrochloride (Zofran) 2 mg/mL in 2-mL singledose vials and 20-mL multidose vials. Also available as 32 mg in a 50-mL premixed container. 

Commercially available containers for use with parenteral products include single-dose ampuls that are heat sealed and opened by snapping at the point of least diameter, vials for multidose use, and botdes and pHable bags that are used for large volumes such as needed in intravenous infusions. Container size can vary from 1 mL to 1 L. Generally volumes up to 100 mL are available as ampuls or vials. 

Parenteral 3-50 million units in vials or multidose pens Interferon beta-la (Avonex, Rebif)... 

Parenteral preparations are filled into various types of containers, depending on the nature of the product. Single-dose injections are filled into glass ampoules sealed by fusion or ex tempore into plastic syringes. Multidose injections are delivered in glass vials sealed with rubber closures with mechanical properties suitable for multiple piercing. Concentrates and powders for injections or infusions are also... 

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