HYDRAVOL IV- hydroxyethyl starch, sodium chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROXYETHYL STARCH 130/0.4 (UNII: 1GVO236S58) (HYDROXYETHYL STARCH 130/0.4 - UNII:1GVO236S58)

Available from:

Vedco, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

HYDRAVOL IV™ acts as plasma volume substitute for the treatment and prophylaxis of hypovolemia. It is not a substitute for red blood cells or coagulation factors in plasma. The use of HYDRAVOL IV™ is contraindicated in the following conditions: - Known hypersensitivity to hydroxyethyl starch. - Fluid overload (hyperhydration) and especially in cases of pulmonary edema and congestive heart failure. - Renal failure with oliguria or anuria not related to hypovolemia. - Patients receiving dialysis treatment. - Severe hypernatremia or severe hyperchloremia. - Intracranial bleeding.

Product summary:

HYDRAVOL IV™ (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) for intravenous infusion is supplied in the following primary container: Polyolefin bag with overwrap: 250 mL and 500 mL Manufactured For: Vedco, Inc. 5503 Corporate Dr. St Joseph, MO 64507 USA For a Copy of the Safety Data Sheet (SDS) or to report adverse reactions call Vedco, Inc. customer service 1 [phone]

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDRAVOL IV- HYDROXYETHYL STARCH, SODIUM CHLORIDE INJECTION, SOLUTION
VEDCO, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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HYDRAVOL IV™
6% HYDROXYETHYL STARCH 130/0.4 IN 0.9% SODIUM CHLORIDE INJECTION
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A
LICENSED VETERINARIAN
STERILE NONPYROGENIC SOLUTION
For Animal Use Only
DESCRIPTION
HYDRAVOL IV™ (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
injection) is a sterile,
non-pyrogenic solution indicated for the treatment and prophylaxis of
hypovolemia. It is not a substitute
for red blood cells or coagulation factors in plasma. May be
administered via intravenous infusion using
aseptic technique. It contains no antimicrobial agents.
Composition, Osmolarity, pH, Ionic Concentration HYDRAVOL IV™ 250 mL
and 500 mL:
The container is free of PVC and phthalates
CLINICAL PHARMACOLOGY
HYDRAVOL IV™ contains hydroxyethyl starch in a colloidal solution
which expands plasma volume
when administered intravenously. Hydroxyethyl starch is a derivative
of thin boiling waxy corn starch,
which mainly consists of a glucose polymer (amylopectin). Substitution
of hydroxyethyl groups on the
glucose units of the polymer reduces the normal degradation of
amylopectin by α-amylase in the body.
INDICATIONS
HYDRAVOL IV™ acts as plasma volume substitute for the treatment and
prophylaxis of hypovolemia.
It is not a substitute for red blood cells or coagulation factors in
plasma.
CONTRAINDICATIONS
The use of HYDRAVOL IV™ is contraindicated in the following
conditions:
Known hypersensitivity to hydroxyethyl starch.
Fluid overload (hyperhydration) and especially in cases of pulmonary
edema and congestive heart
failure.
Renal failure with oliguria or anuria not related to hypovolemia.
Patients receiving dialysis treatment.
Severe hypernatremia or severe hyperchloremia.
Intracranial bleeding.
WARNINGS
Anap