BETAVET- betamethasone sodium phosphate and betamethasone acetate injection, suspension

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

BETAMETHASONE ACETATE (UNII: TI05AO53L7) (BETAMETHASONE - UNII:9842X06Q6M), BETAMETHASONE SODIUM PHOSPHATE (UNII: 7BK02SCL3W) (BETAMETHASONE - UNII:9842X06Q6M)

Pieejams no:

American Regent, Inc.

SNN (starptautisko nepatentēto nosaukumu):

BETAMETHASONE ACETATE

Kompozīcija:

BETAMETHASONE ACETATE 2.85 mg in 1 mL

Ievadīšanas:

INTRA-ARTICULAR

Receptes veids:

PRESCRIPTION

Ārstēšanas norādes:

BETAVET is contraindicated in horses with hypersensitivity to betamethasone. Intra-articular injection of corticosteroids for local effect is contraindicated in the presence of septic arthritis.

Produktu pārskats:

BETAVET, containing 30 mg betamethasone/5 mL (6 mg betamethasone/mL) in 5 mL vials. NDC 10797-720-01     5 mL VIALS     Packaged in boxes of 1 SHAKE WELL BEFORE USING Approved by FDA under NADA # 141-418 AMERICAN REGENT, INC. ANIMAL HEALTH Shirley, NY 11967 (1-888-354-4857) Rev. 8/2021 RQ1053-A

Autorizācija statuss:

New Animal Drug Application

Produkta apraksts

BETAVET- BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE
ACETATE INJECTION, SUSPENSION
AMERICAN REGENT, INC.
----------
BETAVET (BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE
INJECTABLE SUSPENSION)
6 mg betamethasone per mL
For Intra-Articular (I.A.) Use in Horses
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A
LICENSED VETERINARIAN.
DESCRIPTION
BETAVET
is a sterile aqueous suspension of betamethasone acetate in
betamethasone
sodium phosphate injection. The combined betamethasone content of the
suspension is
6 mg/mL where each mL contains 3.15 mg betamethasone (as betamethasone
sodium
phosphate); 2.85 mg betamethasone (as betamethasone acetate); 7.1 mg
dibasic
sodium phosphate; 3.4 mg monobasic sodium phosphate; 0.1 mg edetate
disodium;
and 0.2 mg benzalkonium chloride, as a preservative in water for
injection. The pH is
adjusted to between 6.8 and 7.2.
The formula for betamethasone sodium phosphate is C
H
FNa O P and it has a
molecular weight of 516.41. Chemically, it is
9-Fluoro-11β,17,21-trihydroxy-16β-
methylpregna-1,4-diene-3,20-dione 21-(disodium phosphate).
The formula for betamethasone acetate is C
H
FO and it has a molecular weight of
434.50. Chemically, it is
9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-
3,20-dione 21-acetate.
The chemical structures for betamethasone sodium phosphate and
betamethasone
acetate are as follows:
BETAMETHASONE SODIUM PHOSPHATE
®
®
22
28
2
8
24
31
6
BETAMETHASONE ACETATE
Betamethasone sodium phosphate is a white to practically white,
odorless powder, and
is hygroscopic. It is freely soluble in water and in methanol, but is
practically insoluble in
acetone and in chloroform.
Betamethasone acetate is a white to creamy white, odorless powder that
sinters and
resolidifies at about 165ºC, and remelts at about 200ºC-220ºC with
decomposition. It is
practically insoluble in water, but freely soluble in acetone, and is
soluble in alcohol and in
chloroform.
INDICATION
BETAVET is indicated for the control of pain and inflammation