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Survanta Frequently Asked Questions
We frequently receive requests for information concerning Survanta (beractant) intratracheal suspension, a modified natural bovine surfactant indicated for the treatment and prevention of Respiratory Distress Syndrome (RDS) in premature infants. As a service to health care professionals, Abbott Nutrition medical personnel respond to these requests and, over the years, some well-researched responses have emerged for the most commonly asked questions. We have included several of the questions and the responses here for your convenience.
Single-Entry Vials
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Q. Can more than one dose of Survanta be drawn out of a vial?
A. Survanta is supplied as a single-use vial, and the product does not contain antimicrobial preservatives, which are required in multiple use containers to inhibit the growth of microorganisms.1 Preservatives are not included in the Survanta formulation because of their questionable safety in the premature population (e.g., benzyl alcohol). Because Survanta does not contain preservatives, the vial should not be entered more than once.
If, based on an infant's weight, a vial may supply more than one dose, more than one dosing
syringe can be filled at the time of vial entry, provided aseptic technique is used. Filled syringes
not used immediately may be stored in the refrigerator for a maximum of eight (8) hours before
use. Once removed from the refrigerator, the drug in a syringe should be used immediately after
being brought to room temperature or discarded.
1. <51> Antimicrobial Preservatives - Effectiveness. USP: 24: NF 19: 1809. United States
Pharmacopeial Convention, Inc, Rockville, MD, 1999.
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Color of Survanta
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Q. Is there anything wrong with the vials of drug we just received if the color is different from
previously received drug?
A. The color of Survanta is off-white to light brown. There may be variations within this range,
from batch to batch. Each Survanta vial is visually inspected and judged to be within our
specifications for appearance and color before it is released. Do not use the drug from a vial if
it looks markedly discolored relative to your prior experience (e.g., dark brown). Please return
the vial for analysis, packed with ice packs, to Product Complaint Coordinator, Abbott Laboratories Inc.,
HPD-Building AP4A, Department 0416, One Abbott Park Road, Abbott Park, IL 60064, together
with a letter explaining the appearance of the drug in the vial at the time of shipment and a
history of the storage and handling of the vial. Please call the Abbott toll-free number
(1-800-255-5162) to receive additional directions for returning product.
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Foaminess
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Q. Can a vial of Survanta still be used if it looks foamy when removed from the carton?
A. A small amount of foaming on the surface (up to 0.5 cm) may occur during routine handling
and is inherent to the product. Therefore, if the vial has not been shaken, it is acceptable to use
the drug provided that the extent of foaming does not prohibit accurate dosing. A large amount
of foaming (more than 0.5 cm) may indicate that the vial has been shaken and the product
should not be used. Vigorous shaking will induce foaming and the presence of foam will prohibit
accurate measurement of the dose. |
Refrigeration of Survanta
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Q. How long can a vial of Survanta remain unrefrigerated before it should be discarded?
A. A vial may remain at room temperature continuously for a maximum of twenty-four (24) hours.
In order to ensure stability of the drug, vials left out of the refrigerator for longer than 24 hours
should not be used and should be discarded.
Survanta vials can be carried through one cycle of removal and exposure to room temperature
for a maximum of 24 hours and subsequent return to the refrigerator. Once a vial is returned
to room temperature a second time, it must be used within 24 hours or discarded.
Q. What is the impact on stability when a vial of Survanta is sent through the pneumatic tube
system of a hospital?
A. We currently have no data to support the stability of Survanta when the drug is subjected
to the forces encountered in a pneumatic tube system. Intuitively, we have no reason to suspect
that this practice would be detrimental to the product. Because pneumatic tube conditions may
vary greatly from hospital to hospital, it is not possible for us to conduct a study that we could
be confident would mimic all potential circumstances. If such practice results in excessive
foaming or bubbles, the sending of the drug via pneumatic tube system should be discontinued.
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Osmolality
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Q. What is the osmolality of Survanta?
A. The osmolality of Survanta is approximately 310 mOsm/kg H2O.
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pH of Survanta
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Q. What is the pH range of Survanta?
A. The pH range of Survanta is 6.2 - 7.6.
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* IMS DDD Lung Surfactant Market Purchases July 1991 through June 2007. On file, Abbott Nutrition Marketing Research.
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