DEXIUM-SP- dexamethasone sodium phosphate injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Dostępny od:

Bimeda, Inc.

INN (International Nazwa):

DEXAMETHASONE SODIUM PHOSPHATE

Skład:

DEXAMETHASONE 3 mg in 1 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION

Wskazania:

INDICATIONS AND USAGE: Dexamethasone sodium phosphate injection is indicated as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses. CONTRAINDICATIONS: Do not use in viral infections. Except when used for emergency therapy, dexamethasone sodium phosphate is contraindicated in animals with tuberculosis and chronic nephritis. Existence of congestive heart failure, osteoporosis and diabetes are relative contraindications. In the presence of infection appropriate antibacterial agents should also be administered and should be continued for at least 3 days after discontinuance of the hormone and disappearance of all signs of infection.

Podsumowanie produktu:

HOW SUPPLIED: Dexium-SP™, dexamethasone sodium phosphate injection 4 mg/mL (equivalent to 3 mg/mL dexamethasone) is available in 100 mL multiple dose vials.

Status autoryzacji:

Abbreviated New Animal Drug Application

Charakterystyka produktu

DEXIUM-SP- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION
BIMEDA, INC.
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DEXIUM-SP™
(DEXAMETHASONE SODIUM PHOSPHATE)
INJECTION USP FOR HORSES
4 MG/ML
EQUIVALENT TO DEXAMETHASONE 3 MG/ML
MULTIPLE DOSE VIAL STERILE
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
ANADA #200-317, Approved by FDA
NET CONTENTS: 100ML
FOR INTRAVENOUS USE IN HORSES ONLY
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
WARNING: DO NOT USE IN HORSES INTENDED FOR FOOD
DESCRIPTION:
Dexamethasone sodium phosphate (a synthetic adrenocortical steroid),
is a white or
slightly yellow crystalline powder. It is freely soluble in water and
is exceedingly
hygroscopic. Each mL of sterile aqueous solution contains
Dexamethasone Sodium
Phosphate 4 mg (equivalent to dexamethasone 3 mg), Sodium Citrate 10
mg, Sodium
Bisulfite 2 mg, Benzyl Alcohol 1.5% as preservative, in Water for
Injection q.s. Sodium
Hydroxide and/or Hydrochloric Acid to adjust pH to between 7.0 and
8.5.
CLINICAL PHARMACOLOGY:
Dexamethasone is a synthetic corticosteroid and possesses
glucocorticoid activity.
Dexamethasone sodium phosphate is a salt of dexamethasone that is
particularly
suitable for intravenous administration because it is highly water
soluble, permitting
administration of relatively large doses in a small volume of diluent.
Dexamethasone, as a
steroid, is equivalent in potency to some established steroids while
being considerably
more potent that others. In the case of the dog, dexamethasone is
found to be about
equivalent in dosage to prednisone but about 30 to 40 times more
potent than
prednisolone.
INDICATIONS AND USAGE:
Dexamethasone sodium phosphate injection is indicated as a rapid
adrenal
glucocorticoid and/or anti-inflammatory agent in horses.
CONTRAINDICATIONS:
Do not use in viral infections. Except when used for emergency
therapy,
dexamethasone sodium phosphate is contraindicated in animals with
tuberculosis and
chronic nephritis. Existence of congestive heart failure, osteoporosis
and diabetes a