Osurnia: Product Information (Page 2 of 2)

ANIMAL SAFETY:

In a target animal safety study, 24 mixed breed dogs (4 dogs/sex/group) were aurally administered 0×, 1× (1 mL/ear or 2 mL/dog with repeated administration in 7 days) or 5× (5 mL/ear or 10 mL/dog with repeated administration in 7 days) doses of OSURNIA for a total of 6 administrations in 5 weeks. All dogs remained in good health with normal hearing throughout the study. Decreased weight gain was noted in the 1× and 5× groups compared to the control group. Clinical findings included post-administration ear wetness in 1× and 5× groups and unilateral, transient brown/red discharge from one ear each in two 5× dogs, with erythema in one dog after the 4th application. Local microscopic changes in ears (without clinical effects) included: slight or moderate unilateral vesicle formation within the epithelium of the tympanic membrane in two 1× and four 5× dogs, and unilateral mucosal ulceration in the lining of the middle ear cavity in three 5× dogs. Three 5× dogs had slightly elevated ALT activity, accompanied by minimal or mild microscopic hepatocellular vacuolation (in two dogs). Cortisol response to ACTH stimulation was decreased, but within the normal reference range, in 1× dogs. The 5× dogs had a decrease in serum cortisol levels after ACTH stimulation (below normal reference range) accompanied by decreased adrenal gland and thymic weights with minimal adrenal cortical atrophy and slight (in three dogs) or moderate (in one dog also noted with slightly lower lymphocyte counts) lymphoid depletion of the thymus. The ACTH stimulation test results are consistent with systemic absorption of betamethasone resulting in a likely reversible suppression of the hypothalamic-pituitary-adrenal axis as seen with administration of exogenous corticosteroids.

STORAGE CONDITIONS:

OSURNIA should be stored under refrigerated conditions between 36° — 46° F (2° — 8° C). To facilitate comfort during administration, OSURNIA may be brought to room temperature and stored for up to three months.

HOW SUPPLIED:

OSURNIA is a gel in a single use tube with a flexible soft tip, supplied in cartons containing 2 or 20 tubes.

Osurnia 2 tube carton NDC 17033-283-02
Osurnia 20 tube carton NDC 17033-283-20

Approved by FDA under NADA # 141-437

MANUFACTURED FOR:
Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211 USA

Product of Great Britain

Rev. June 2020 PIL-44029-001

PRINCIPAL DISPLAY PANEL — 1 Dose Tube Label

TUB-44029-001
Twist to open

Osurnia®
(florfenicol, terbinafine,
betamethasone acetate)

Otic gel for dogs

1 dose

Dechra

Lot/Exp

PRINCIPAL DISPLAY PANEL -- 1 Dose Tube Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2 Tube Carton

Osurnia®

(florfenicol, terbinafine, betamethasone acetate)
Otic gel for dogs

Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
Approved by FDA under NADA # 141-437

2 Tubes

Dechra

PRINCIPAL DISPLAY PANEL -- 2 Tube Carton
(click image for full-size original)
OSURNIA
florfenicol, terbinafine, betamethasone acetate gel
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17033-283
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
florfenicol (florfenicol) florfenicol 10 mg in 1 mL
terbinafine (terbinafine) terbinafine 10 mg in 1 mL
betamethasone acetate (betamethasone) betamethasone acetate 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
OLEIC ACID
HYDROGENATED SOYBEAN LECITHIN
HYPROMELLOSE, UNSPECIFIED
PROPYLENE CARBONATE
GLYCEROL FORMAL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17033-283-02 2 TUBE, WITH APPLICATOR in 1 CARTON contains a TUBE, WITH APPLICATOR
1 1 mL in 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (17033-283-02)
2 NDC:17033-283-20 20 TUBE, WITH APPLICATOR in 1 CARTON contains a TUBE, WITH APPLICATOR
2 1 mL in 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (17033-283-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141437 05/01/2015
Labeler — Dechra Veterinary Products (362142734)

Revised: 05/2021 Dechra Veterinary Products

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