KENALOG-40 (Page 5 of 5)

SYSTEMIC

For systemic therapy, injection should be made deeply into the gluteal muscle (see WARNINGS). For adults, a minimum needle length of 1½ inches is recommended. In obese patients, a longer needle may be required. Use alternative sites for subsequent injections.

LOCAL

For treatment of joints, the usual intra-articular injection technique should be followed. If an excessive amount of synovial fluid is present in the joint, some, but not all, should be aspirated to aid in the relief of pain and to prevent undue dilution of the steroid.

With intra-articular administration, prior use of a local anesthetic may often be desirable. Care should be taken with this kind of injection, particularly in the deltoid region, to avoid injecting the suspension into the tissues surrounding the site, since this may lead to tissue atrophy.

In treating acute nonspecific tenosynovitis, care should be taken to ensure that the injection of the corticosteroid is made into the tendon sheath rather than the tendon substance. Epicondylitis may be treated by infiltrating the preparation into the area of greatest tenderness.

HOW SUPPLIED

Product: 50090-2360

NDC: 50090-2360-0 1 mL in a VIAL, SINGLE-DOSE

Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
Product of Spain

1221153A7

Revised: January 2016

TRIAMCINOLONE ACETONIDE

Label ImageLabel Image
KENALOG-40
triamcinolone acetonide injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2360(NDC:0003-0293)
Route of Administration INTRAMUSCULAR, INTRA-ARTICULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride
benzyl alcohol
polysorbate 80
sodium hydroxide
hydrochloric acid
nitrogen
CARBOXYMETHYLCELLULOSE SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2360-0 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (50090-2360-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA014901 06/01/2009
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2360)

Revised: 11/2016 A-S Medication Solutions

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