HYDRAVOL IV™

6% HYDROXYETHYL STARCH 130/0.4 IN 0.9% SODIUM CHLORIDE INJECTION

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CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN

 

STERILE NONPYROGENIC SOLUTION

For Animal Use Only

  1. 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 contain no antimicrobial agents.

 

Composition, Osmolarity, pH, Ionic Concentration HYDRAVOL IV™ 250 mL and 500 mL:

 

TABLE 1. PRODUCT INFORMATION/ COMPOSITION/OSMOLARITY/PH/IONIC CONCENTRATION

 

IONIC Concentration

 

PRODUCT

 

Composition (g/L) HYDROXYETHYL STARCH 130/0.4

Composition (g/L) SODIUM CHLORIDE

NaCl

 

Osmolarity (mOsmol/L) (calc)

 

pH

 

SODIUM

 

CHLORIDE

 

HYDRAVOL IV™ 250 mL

 

60

 

9.0

 

308

 

4.0-5.5

 

154

 

154

 

HYDRAVOL IV™ 500 mL

 

60

 

9.0

 

308

 

4.0-5.5

 

154

 

154

 

The container is free of PVC and phthalates

 

  1. 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.

  1. INDICATIONS

HYDRAVOL IV™ acts as a plasma volume substitute for the treatment and prophylaxis of hypovolemia. It is not a substitute for red blood cells or coagulation factors in plasma.

  1. CONTRAINDICATIONS

The use of HYDRAVOL IV™ is contraindicated in the following conditions:

  • Known hypersensitivity to hydroxyethyl
  • Fluid overload (hyperhydration) and especially in cases of pulmonary edema and congestive heart
  • Renal failure with oliguria or anuria not related to
  • Patients receiving dialysis
  • Severe hypernatremia or severe
  • Intracranial
  1. 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.

  1. ADVERSE REACTIONS
    • Products containing hydroxyethyl starch may lead to Anaphylactoid/hypersensitivity
    • Prolonged administrations of high dosages of hydroxyethyl starch may cause pruritus (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
  1. PRECAUTIONS
    • Do not administer unless solution is clear and seal is
    • This is a single dose unit. It contains no
    • Use entire contents when first
    • 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
  2. DRUG INTERACTIONS

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

  1. DOSAGE AND ADMINISTRATION
    • To be used as directed by a licensed 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 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 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 1 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).
  1. 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.

  1. DIRECTION 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
  2. Remove plastic protector from inlet/outlet port at bottom of
  3. Attach administration

Warning: Do not introduce additives into this container.

  1. STORAGE

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

  1. 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

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