Facilipro Hand Sanitizer

Facilipro Hand Sanitizer

Facilipro Hand Sanitizer Recall

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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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.

History

There is currently no drug history available for this drug.

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)]

Facilipro Hand Sanitizer Manufacturers


  • Ecolab Inc.
    Facilipro Hand Sanitizer (Alcohol) Solution [Ecolab Inc.]

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