HYDRAVOL IV- hydroxyethyl starch, sodium chloride injection, solution

HydraVol IV by

Drug Labeling and Warnings

HydraVol IV by is a Animal medication manufactured, distributed, or labeled by Vedco, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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.

ADVERSE REACTIONS

• Products containing hydroxyethyl starch may lead to Anaphylactoid/hypersensitivity reactions.
• Prolonged administrations of high dosages of Hydroxyethyl starch may cause prutirus (itching), hemodilution (resulting in dilution of blood components, e.g., coagulation factors and other plasma proteins, and in a decrease in hematocrit).
• If an adverse reaction does occur, discontinue the infusion and evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.

PRECAUTIONS

• Do not administer unless solution is clear and seal is intact.
• This is a single dose unit. It contains no preservatives.
• Use entire contents when first opened.
• Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy, or whenever the patient's condition warrants such evaluation.

DRUG INTERACTIONS

No interactions with other drugs or nutritional products are known. The safety and compatibility of additives have not been established.

DOSAGE AND ADMINISTRATIONS

• To be used as directed by a licensed veterinarian. HYDRAVOL IV™ 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).
• For use in one patient on one occasion only. Discard any unused portion. Care should be taken with administration technique to avoid administration site reactions and infection.
• HYDRAVOL IV™ can be administered repetitively over several days. The initial 10 to 20 mL should be infused slowly, keeping the patient under close observation due to possible anaphylactoid reactions. See Warnings and Precautions.

ADULT DOSE

• As a general recommendation, the class of synthetic colloids are prescribed at doses up to 20 mL per kg of body weight per day in small animal patient1​. In a 30 kg patient, this is a dose of 600 mL of HYDRAVOL IV™ (equivalent to 1.2 g hydroxyethyl starch and 3.1 mEq sodium per kg of body weight).

OVERDOSAGE

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.

DIRECTIONS FOR USE OF PLASTIC CONTAINER

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

1. Suspend container from eyelet support.
2. Remove plastic protector from inlet/outlet port at bottom of container.
3. Attach administration set.

Warning: Do not introduce additives into this container.

STORAGE

Store at 15°C to 25°C (59°F to 77°F). Do not freeze.

HOW SUPPLIED

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

References

1. Silverstein D, Hopper K. Small Animal Critical Care Medicine. (2009)

Principal Display Panel

NDC: 50989-888-15

HydraVol IV™

6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection

FOR INTRAVENOUS INFUSION ONLY

250mL

NDC: 50989-888-16

HydraVol IV™

6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection

FOR INTRAVENOUS INFUSION ONLY

500mL

INGREDIENTS AND APPEARANCE

HYDRAVOL IV 
hydroxyethyl starch, sodium chloride injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 50989-888
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROXYETHYL STARCH 130/0.4 (UNII: 1GVO236S58) (HYDROXYETHYL STARCH 130/0.4 - UNII:1GVO236S58)	HYDROXYETHYL STARCH 130/0.4	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)	900 mg  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50989-888-15	250 mL in 1 CONTAINER
2	NDC: 50989-888-16	500 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/24/2018

Labeler - Vedco, Inc. (021634266)

Registrant - Vedco, Inc. (021634266)