HydraVol IV 6% Hydroxyenthyl Starch 130/0.4 in 0.9% Sodium Chloride Injection (250 mL)

HydraVol IV 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.

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.

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 anaphylactoidreactions. 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 patients. In a 30 kg patient, this is a dose of 600 mL of HYDRAVOL IV (equivalent to 1.2 g hydroxyethylstarch and 3.1 mEqsodium 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.

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

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
• 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).

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.

Drug Interactions

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

Storage:

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