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Facilipro Hand Sanitizer

Facilipro Hand Sanitizer Recall

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Uses

6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is indicated for the treatment and prophylaxis of hypovolemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma.

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Other Information

6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is a clear to slightly opalescent, colorless to slightly yellow, sterile, non-pyrogenic, isotonic solution for intravenous administration using sterile equipment.

Each 100 mL of the solution contains:
Hydroxyethyl Starch 130/0.4……………………………………..6 g
Sodium Chloride USP………………………………………………900 mg
Water for Injection USP…………………………………………….qs

In addition, as required sodium hydroxide may be added to adjust the final pH so the final solution pH is 4.0 to 5.5.

The electrolyte composition is as follows (mEq/L): Sodium 154, Chloride 154.

The calculated osmolarity is 308 mOsmol/L.

The hydroxyethyl starch contained in 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is a synthetic colloid for use in plasma volume replacement. The chemical name of hydroxyethyl starch is poly(O-2-hydroxyethyl) starch. The structural formula of hydroxyethyl starch is

Structural Formula

R = -H, -CH2CH2OH
R1 = -H, -CH2CH2OH or glucose units

Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. [see Directions for Use of EXCEL® Container (2.3)]

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Facilipro Hand Sanitizer Manufacturers

  • Ecolab Inc.
    Facilipro Hand Sanitizer | B. Braun Medical Inc.
    No Recall

    Facilipro Hand Sanitizer | B. Braun Medical Inc.

    Facilipro Hand Sanitizer | B. Braun Medical Inc.

    6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is administered by intravenous infusion only. The daily dose and rate of infusion depend on the patient's blood loss, on the maintenance or restoration of hemodynamics and on the hemodilution (dilution effect). 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injectioncan be administered repetitively over several days. [see Warnings and Precautions (5)] 

    The initial 10 to 20 mL should be infused slowly, keeping the patient under close observation due to possible anaphylactoid reactions. [see General Warnings and Precautions (5.1)]

    2.1 Adult Dose

    Up to 50 mL of 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection per kg of body weight per day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to 3500 mL of 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection for a 70 kg patient.

    2.2 Pediatric Dose

    The dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status. 

    In 41 newborns to infants (< 2 years), a mean dose of 16 ± 9 mL/kg was administered. In 31 children from 2 to 12 years of age a mean dose of 36 ± 11 mL/kg was administered. The dose in adolescents > 12 is the same as the adult dose. [see Pediatric Use (8.4)]

    2.3 Directions for Use of EXCEL® Container

    Caution: Do not use plastic container in series connection.

    If administered by pressure infusion, air should be withdrawn or expelled from the bag through the medication/administration port prior to infusion.

    To Open
    Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired.

    Note: Before use, perform the following checks:

    Read the label carefully. Do not remove the plastic infusion container from its overwrap until immediately before use. While the overwrap is intact, identify the solution as 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, the lot number, and the expiration date. Check that the solution is clear. Inspect the intact unit for signs of obvious damage. If present, the unit should not be used. Use only if solution is clear and container and seals are intact.

    Preparation for Administration
    1. Remove plastic protector from sterile set port at bottom of container.
    2. Attach administration set. Refer to complete directions accompanying set.

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