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Animal NDC 69043-057-02 Detomised

Detomidine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 69043-057-02
Proprietary Name Detomised What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Detomidine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Cronus Pharma Llc
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Detomidine Hydrochloride
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200611 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

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Detomised Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Sedative and Analgesic For Use in Horses Only

Sterile solution

10 mg/mL


Chemical Structure



Each mL of DetomiSed™ contains 10.0 mg detomidine hydrochloride, 1.0 mg methyl paraben, 5.9 mg sodium chloride, and water for injection, q.s.


Contact Information



To report suspected adverse drug experience, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Cronus Pharma LLC at 1-844-227-6687 or 1-844-2-CRONUS.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae


Dosage And Administration:



For Sedation: Administer DetomiSed™ IV or IM at the rates of 20 or 40 mcg detomidine hydrochloride per kg of body weight (0.2 or 0.4 mL of DetomiSed™ per 100 kg or 220 lb), depending on the depth and duration of sedation required. Onset of sedative effects should be reached within 2 to 4 minutes after IV administration and 3 to 5 minutes after IM administration. Twenty mcg/kg will provide 30 to 90 minutes of sedation and 40 mcg/kg will provide approximately 90 minutes to 2 hours of sedation.

For Analgesia: Administer DetomiSed™ IV at the rates of 20 or 40 mcg detomidine hydrochloride per kg of body weight (0.2 or 0.4 mL of DetomiSed™ per 100 kg or 220 lb), depending on the depth and duration of analgesia required. Twenty mcg/kg will usually begin to take effect in 2 to 4 minutes and provide 30 to 45 minutes of analgesia. The 40 mcg/kg dose will also begin to take effect in 2 to 4 minutes and provide 45 to 75 minutes of analgesia.

For Both Sedation and Analgesia: Administer DetomiSed™ IV at the rates of 20 or 40 mcg detomidine hydrochloride per kg of body weight (0.2 or 0.4 mL of DetomiSed™ per 100 kg or 220 lb), depending on the depth and duration of sedation and analgesia required.

Before and after injection, the animal should be allowed to rest quietly.


Package Label.Principal Display Panel



NDC 69043-057-02

DetomiSedTM

(detomidine hydrochloride)

Sedative and Analgesic
For Use in Horses Only

Sterile Solution - 10 mg/mL

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

Approved by FDA under ANADA # 200-611

Net Contents: 20 mL


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.