Ketofen: Product Information (Page 3 of 3)

TARGET ANIMAL SAFETY

Margin of Safety : KETOFEN® was injected with a 1X (3 mg/kg BW), 3X (9 mg/kg BW), and 5X (15 mg/kg BW) dose daily for 9 consecutive days (3 times the maximum recommended duration). The only treatment-associated finding present at a 1X (3 mg/kg BW) dose for 9 days was minimal to mild gross and microscopic renal tubular lesions. No ketoprofen-related changes were noted in clinical or general health observations, hematology, urinalysis, fecal occult blood, or serum chemistries in cattle administered a 1X (3 mg/kg BW) dose for 9 days. At a 3X dose, subclinical focal ulcers in the abomasum and minimal to mild renal lesions were present. Cattle injected with a 5X dose of ketoprofen for 9 days had similar treatment related findings, except for one of eight calves which had clinical signs of toxicity, due to peritonitis subsequent to abomasal ulceration on the 9th treatment day. Discontinue treatment if fecal blood is observed. Do not use in cattle that are dehydrated or with known renal disease.
Injection site safety : Eight calves were injected with a 1X dose of ketoprofen daily for 3 consecutive days with clinical observations of injection sites with necropsy on days 7, 14, 28, and 42. Injection of 3 consecutive doses of KETOFEN® resulted in transient injection site reactions palpable through 14 days, with resolution by 28 days post-administration. Injection site lesions included discoloration involving the skin and subcutaneous tissue on Day 7. By Day 42 discoloration was limited to subcutaneous tissue. Subcutaneous injection of ketoprofen can cause a transient local tissue reaction. These reactions may result in trim loss of edible tissue at slaughter.
Field safety : There were no adverse events reported in investigational field studies with the injection of KETOFEN® under the intended conditions of use.

REFERENCES

1. Paresh B, R.s., RD Varia, JH Patel, UD Patel, SK Bhavsar and AM Thaker, Impact of multiple intravenous administrations of ketoprofen on blood profile in cow calves. Inter J Vet Sci, 2012. 1(1): p. 34-36.

HOW SUPPLIED

KETOFEN® (ketoprofen) 100 mg/mL is available in 50 mL and 100 mL multidose bottles.

STORAGE CONDITIONS

Store below 25°C (77°F), with brief excursions permitted between 0°C — 40°C (32°F — 104°F).

Approved by FDA under NADA # 140-269
zoetis
Manufactured by:
Zoetis Manufacturing and Research Spain, S.L.
Girona, Spain
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
Revised: April 202140029077

PRINCIPAL DISPLAY PANEL — 50 mL Bottle Label

50 mL Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mL Bottle Label

100 mL Bottle Label
(click image for full-size original)

KETOFEN ketoprofen injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-4396
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOPROFEN (KETOPROFEN) KETOPROFEN 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARGININE 70 mg in 1 mL
CITRIC ACID MONOHYDRATE
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-4396-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (54771-4396-1)
2 NDC:54771-4396-2 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 mL in 1 BOTTLE This package is contained within the CARTON (54771-4396-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140269 09/26/1990
Labeler — Zoetis Inc. (828851555)

Revised: 06/2021 Zoetis Inc.

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