DEXAMETHASONE SP- dexamethasone sodium phosphate injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

Dexamethasone Sodium Phosphate (UNII: AI9376Y64P) (Dexamethasone - UNII:7S5I7G3JQL)

Διαθέσιμο από:

MWI/VetOne

INN (Διεθνής Όνομα):

Dexamethasone Sodium Phosphate

Σύνθεση:

Dexamethasone 3 mg in 1 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION

Θεραπευτικές ενδείξεις:

INDICATIONS AND USAGE: Dexamethasone-SP (dexamethasone sodium phosphate) 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.

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Abbreviated New Animal Drug Application

Αρχείο Π.Χ.Π.

DEXAMETHASONE SP- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION
MWI/VETONE
----------
DEXAMETHASONE-SP
(dexamethasone sodium phosphate)
INJECTION USP FOR HORSES
4 MG/ML
EQUIVALENT TO DEXAMETHASONE 3 MG/ML
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
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
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 Dexamethasone-SP (dexamethasone sodium phosphate) contains
Dexamethasone Sodium Phosphate 4 mg (equivalent to dexamethasone 3
mg), Sodium
Citrate 10 mg, Sodium Bisulfite 2 mg, Benzyl Alcohol 1.5% as a
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 corticosteriod 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 than 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-SP (dexamethasone sodium phosphate) 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