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.
----------
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
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
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.
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:
Anaphylactoid reactions (bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema) have been reported with solutions containing hydroxyethyl starch. If a hypersensitivity reaction occurs, administration of the drug should be discontinued immediately, and the appropriate treatment and supportive measures should be undertaken until symptoms have resolved.
Fluid status and rate of infusion should be assessed regularly during treatment, especially in patients with cardiac insufficiency or severe kidney dysfunction.
In cases of severe dehydration, a crystalloid solution should be given first. Generally, sufficient fluid should be administered in order to avoid dehydration.
Caution should be observed before administering HYDRAVOL IV™ to patients with severe liver disease or severe bleeding disorders. With the administration of certain hydroxyethyl starch solutions, disturbances of blood coagulation can occur depending on the dosage.
If administered by pressure infusion, air should be withdrawn or expelled from the bag through the administration port prior to infusion.
Do not introduce additives into this container.
No interactions with other drugs or nutritional products are known. The safety and compatibility of additives have not been established.
ADULT DOSE
As with all plasma volume substitutes, overdosage can lead to overloading of the circulatory system (e.g., pulmonary edema). In this case, the infusion should be stopped immediately and, if necessary, a diuretic should be administered. See Warnings and Precautions.
To open
Tear overwrap at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
Preparation for administration
Warning: Do not introduce additives into this container.
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 (888) 708-3326
HYDRAVOL IV
hydroxyethyl starch, sodium chloride injection, solution |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Labeler - Vedco, Inc. (021634266) |
Registrant - Vedco, Inc. (021634266) |