VETSTARCH- hydroxyethyl starch 130/0.4 substitution 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:

Zoetis Inc.

INN (International Name):

HYDROXYETHYL STARCH 130/0.4

Composition:

HYDROXYETHYL STARCH 130/0.4 6000 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

VetStarch™ (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is indicated for the treatment and prophylaxis of hypovolemia. It is not a substitute for red blood cells or coagulation factors in plasma. The use of VetStarch™ is contraindicated in the following conditions: • Known hypersensitivity to hydroxyethyl starch [see General Warnings and Precautions (5.1)]  • 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 The type of hydroxyethyl starch present in VetStarch had no teratogenic properties in rats or rabbits. At 5 g/kg of body weight per day, administered as a bolus injection, fetal retardations and embryolethal effects were observed in rats and rabbits, respectively. In rats, a bolus injection of this dose during pregnancy and lactation reduced body

Product summary:

VetStarch™ (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) for intravenous infusion is supplied in the following primary container and carton sizes: Polyolefin bag with overwrap: 250 mL and 500 mL Carton of 20 x 500 mL Carton of 30 x 250 mL Store at 15° to 25°C (59° to 77°F), Do not freeze For Customer Service call  1-888-963-8471 Distributed by: Zoetis Inc. Kalamazoo, MI 49007 Product of Norway

Authorization status:

unapproved drug other

Summary of Product characteristics

VETSTARCH- HYDROXYETHYL STARCH 130/0.4 SUBSTITUTION INJECTION,
SOLUTION
ZOETIS 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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VETSTARCH ™
6% HYDROXYETHYL STARCH 130/0.4 IN 0.9% SODIUM CHLORIDE INJECTION
CAUTION:
Federal Law (USA) restricts this drug to use by or on the order of a
licensed veterinarian.
HIGHLIGHTS OF PRESCRIBING INFORMATION:
These highlights do not include all of the information needed to use
VetStarch safely and effectively.
See full prescribing information for VetStarch.
VETSTARCH™
(6% HYDROXYETHYL STARCH 130/0.4 IN 0.9% SODIUM CHLORIDE INJECTION)
For administration by intravenous infusion.
INDICATIONS AND USAGE:
VetStarch is a plasma volume substitute indicated for the treatment
and prophylaxis of hypovolemia.
DOSAGE AND ADMINISTRATION:
ADMINISTER BY INTRAVENOUS INFUSION ONLY.
•Daily dose and rate of infusion depend on the patient's blood loss,
hemodynamics and on the
hemodilution effects
•Initiate infusion slowly due to possible anaphylactoid reactions
DOSAGE FORMS AND STRENGTHS:
250 ml and 500 ml flexible plastic intravenous solution containers.
Each 100 ml contains 6 g
hydroxyethyl starch 130/0.4 in Isotonic sodium chloride injection.
CONTRAINDICATIONS:
•Known hypersensitivity to hydroxyethyl starch
•Fluid overload e.g., pulmonary edema and congestive heart failure
•Renal failure with oliguria or anuria not related to hypovolemia
•Patients receiving dialysis
•Severe hypernatremia or severe hyperchloremia
•Intracranial bleeding
WARNINGS AND PRECAUTIONS:
•Anaphylactoid and hypersensitivity reactions
•Avoid fluid overload; adjust dosage in patients with cardiac or
renal dysfunction
•In severe dehydration, a crystalloid solution should be given first
•Observe caution in patients with severe liver disease or bleeding
disorders
•Monitor kidney function, fluid balance and serum electrolytes
•In humans elevated seru