Sedexodine: Product Information (Page 5 of 5)

STORAGE:

Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing. Use contents within 90 days of the first puncture.

HOW SUPPLIED:

Sedexodine (dexmedetomidine hydrochloride injection) is supplied in 10 mL, multi-dose vials containing 0.5 mg of dexmedetomidine hydrochloride per mL.

REFERENCES:

  1. Ko JCH, Fox SMF, Mandsager RE. Effects of preemptive atropine administration on incidence of medetomidine-induced bradycardia in dogs. J Am Vet Med Assoc 2001; 218:52-58.
  2. Alibhai HIK, Clarke KW, Lee YH, et al. Cardiopulmonary effects of combinations of medetomidine hydrochloride and atropine sulphate in dogs. Vet Rec 1996; 138:11-13.
  3. Short, CE. Effects of anticholinergic treatment on the cardiac and respiratory systems in dogs sedated with medetomidine. Vet Rec 1991; 129:310-313.
  4. Hikasa Y, Akiba T, lino Y et al. Central alpha-adrenoceptor subtypes involved in the emetic pathway in cats. Eur J Pharmacol 1992; 229:241-251.

Approved by FDA under ANADA # 200-699

Figure

Manufactured for: Akorn, Inc.
Lake Forest, IL 60045

Distributed by: MWIBoise, ID 83705

www.VetOne.net

MWDE00N Rev. 02/21

Principal Display Panel Text for Container Label:

NDC 13985-993-10

VETone® Logo

Sedexodine™

(dexmedetomidine hydrochloride injection)

5 mg/10 mL (0.5 mg/mL)

Sterile Injectable Solution

Sedative, Analgesic and Preanesthetic

For intramuscular and intravenous use in dogs

and for intramuscular use in cats.

Caution: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Approved by FDA under ANADA # 200-699

V1 502019

Net Contents: 10 mL

Figure
(click image for full-size original)

Principal Display Panel Text for Carton Label:

NDC 13985-993-10

VETone® Logo

Sedexodine™

(dexmedetomidine hydrochloride injection)

5 mg/10 mL (0.5 mg/mL)

Sterile Injectable Solution

Sedative, Analgesic and

Preanesthetic

For intramuscular and intravenous

use in dogs and for intramuscular

use in cats.

Caution: Federal law restricts this

drug to use by or on the order of a

licensed veterinarian.

Approved by FDA under

ANADA # 200-699

V1 502019 Net Contents: 10 mL

Figure
(click image for full-size original)
SEDEXODINE dexmedetomidine hydrochloride injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:13985-993
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dexmedetomidine Hydrochloride (Dexmedetomidine) Dexmedetomidine 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Methylparaben
Propylparaben
Sodium Chloride
Water
Hydrochloric Acid
Sodium Hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13985-993-10 1 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 (13985-993-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200699 03/22/2021
Labeler — VETONE (019926120)
Registrant — Akorn Operating Company LLC (117693100)
Establishment
Name Address ID/FEI Operations
Exela Pharma Sciences, LLC. 831274399 MANUFACTURE, PACK, LABEL, ANALYSIS

Revised: 03/2021 VETONE

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