VetaKet: Product Information (Page 2 of 2)

CLINICAL STUDIES:

Ketamine hydrochloride has been clinically studied in subhuman primates in addition to those species listed under Dosage and Administration. Dosages for restraint in these additional species, based on limited clinical data, are: Cercopithecus aethiops (grivet), Papio papio (guinea baboon) 10 to 12 mg/kg; Erythrocebus patas patas (patas monkey) 3 to 5 mg/kg; Hylobates lar (white-handed gibbon) 5 to 10 mg/kg; Lemur catta (ringtailed lemur) 7.5 to 10 mg/kg; Macaca fuscata (Japanese macaque) 5 mg/kg; Macaca speciosa (stumptailed macaque) and Miopithecus talapoin (mangrove monkey) 5 to 7.5 mg/kg; and Symphalangus syndactylus (siamangs) 5 to 7 mg/kg.

Taxonomy from “A Handbook of Living Primates” by Napier and Napier, Academic Press, New York, NY.

AKORN
Animal Health
Manufactured by:
Akorn, Inc.
Lake Forest, IL 60045

VE00N Rev. 09/15

Principal Display Panel Text for Container Label:

NDC 59399-114-10

VetaKet® CIII

KETAMINE HCl

INJECTION, USP

Equivalent to

100 mg per mL Ketamine

10 mL

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

ANADA 200-055, Approved by FDA

Principal Display Panel Text for Container Label
(click image for full-size original)

Principal Display Panel Text for Carton Label:

NDC 59399-114-10

VetaKet® CIII

KETAMINE HCl INJECTION, USP

Equivalent to 100 mg/mL Ketamine

25 x 10 mL

CAUTION: Federal law restricts this drug to use by or on the order of a licensed Veterinarian.

Akorn Animal Health Logo

ANADA 200-055, Approved by FDA

Principal Display Panel Text for Carton Label
(click image for full-size original)
VETAKET
ketamine hydrochloride injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:59399-114
Route of Administration INTRAMUSCULAR DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ketamine Hydrochloride (Ketamine) Ketamine 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzethonium Chloride 0.1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59399-114-10 25 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (59399-114-10)
2 NDC:59399-114-12 12 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
2 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (59399-114-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200055 03/09/2015
Labeler — Akorn Animal Health, Inc. (117696748)
Registrant — Akorn Operating Company LLC (117693100)
Establishment
Name Address ID/FEI Operations
Akorn, Inc 117696790 PACK, LABEL
Establishment
Name Address ID/FEI Operations
Akorn, Inc. 117696832 MANUFACTURE, ANALYSIS, STERILIZE

Revised: 10/2020 Akorn Animal Health, Inc.

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