HYDROSTARCH- hydroxyethyl starch 130/0.4 substitution injection, solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

HYDROXYETHYL STARCH 130/0.4 (UNII: 1GVO236S58) (HYDROXYETHYL STARCH 130/0.4 - UNII:1GVO236S58)

MAH:

ASPEN VETERINARY

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION

therapeutic_indication:

HydroStarch™ act as a plasma volume substitute for the treatment and prophylaxis of hypovolemia in all species. It is not a substitute for red blood cells or coagulation factors in plasma. HydroStarch™ is contraindicated in patients with a 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 and intracranial bleeding.

authorization_status:

unapproved drug other

SPC

HYDROSTARCH- HYDROXYETHYL STARCH 130/0.4 SUBSTITUTION INJECTION,
SOLUTION
ASPEN VETERINARY
_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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HYDROSTARCH
STERILE NONPYROGENIC SOLUTION
For Animal Use Only
DES CRIPTION
HydroStarch™ is a sterile, non-pyrogenic solution as an aid for
hypovolemia. May be administered via
intravenous infusion using aseptic technique. It contains no
antimicrobial agents. Discard any unused
portion. Composition, osmolarity, pH and ionic concentration are shown
in Table 1.
TABLE 1
The container is free of PVC and phthalates. The container meets the
requirements of USP and is
registered with FDA.
CLINICAL PHARMACOLOGY
HydroStarch™ 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
HydroStarch™ act as a plasma volume substitute for the treatment and
prophylaxis of hypovolemia in all
species. It is not a substitute for red blood cells or coagulation
factors in plasma.
CONTRAINDICATIONS
HydroStarch™ is contraindicated in patients with a 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 and 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