Animal NDC 57926-040-01 Finaplix-h
Trenbolone Acetate

Animal Product Information

Field Name Field Value
Animal NDC Code 57926-040-01
Proprietary Name Finaplix-h 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 Trenbolone Acetate 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 Merck Sharp & Dohme Corp.
Product Type Otc Animal Drug
Usage Information
    Increases rate of weight gain and improves feed efficiency in a slow-release delivery system. This product is to be used in feedlot heifers only during approximately the last 63 days prior to slaughter.Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.
Active Ingredient(s)
  • Trenbolone Acetate
Marketing Category NADA - 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 NADA138612 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.

Finaplix-h Images

Finaplix-h 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



For Heifers
Fed In Confinement
For Slaughter

SITE OF IMPLANTATION

After appropriately restraining the animal to allow access to the ear, cleanse the skin at the implant needle puncture site. It is subcutaneous between the skin and cartilage on the back side of the ear and below the midline of the ear. The implant must not be placed closer to the head than the edge of the cartilage ring farthest from the head. The location of insertion of the needle is a point toward the tip of the ear and at least a needle length away from the intended deposition site. Care should be taken to avoid injuring the major blood vessels or cartilage of the ear.

METHOD OF USE

  • Do not remove the cap of the cartridge containing the implants.
  • Place the cartridge (D) with the capped end to the front into slot at the top of the implanter magazine marked (A) on the diagram.
  • Gently push the cartridge into the slot until it clicks into place.
  • The implanter is then ready for use.
  • Take the ear of the animal firmly with the free hand in the manner shown in Fig. 1. Then insert the needle into the subcutaneous tissue at the point indicated in Fig. 2.
  • After inserting the needle to its full extent, squeeze the trigger (E) gradually. Allow the pellets of the implant to be deposited in a single row.
  • Withdraw the implanter. This will advance the cartridge one groove in the magazine and the next implant is now ready for use.
  • When all the implants have been administered, the cartridge will discharge out the bottom of the magazine and may be replaced by a new one.
  • To change the needle, loosen the needle locking nut labeled (F) in Fig. 3 and replace the needle. Tighten the nut finger tight and the implanter is ready for use.

    • Made in Austria by:
    Intervet GesmbH

    Distributed by:
    Intervet Inc (d/b/a Merck Animal Health)
    Madison, NJ 07940

    Restricted Drug (California) - Use only as Directed

    Rev. 03/15

    NADA # 138-612, Approved by FDA

    Finaplix is a registered trademark of Intervet Inc. or an affiliate.

    152443 R1


Description



Finaplix®-H (trenbolone acetate) is an implant containing 200 mg of trenbolone. Each implant consists of 10 small yellow pellets. Ten implants are provided in a cartridge.

Manufactured by a non-sterilizing process.


Indications For Use



Increases rate of weight gain and improves feed efficiency in a slow-release delivery system. This product is to be used in feedlot heifers only during approximately the last 63 days prior to slaughter.

Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.


Dosage & Administration



DOSAGE

One implant containing 200 mg trenbolone acetate is administered to each animal. The 10 pellets which make up the dosage of Finaplix®-H are contained in one division of the multiple dose cartridge. Ten doses are in each cartridge. The cartridge is designed to be used with a special implant gun.

ROUTE OF ADMINISTRATION

The implant is placed under the skin on the posterior aspect of the ear by means of a special implanter available from Intervet Inc.

With the animal suitably restrained, the skin on the outer surface of the ear should be cleaned. The implant is then administered by the method shown in the diagram below.


Warnings



WARNING

Not to be used in animals intended for subsequent breeding, or in dairy animals. For Animal Treatment Only. Not for Use in Humans. Implant pellets in the ear only. Any other location is in violation of Federal Law. Do not attempt salvage of implanted site for human or animal food.

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.


Storage And Handling



STORAGE CONDITIONS

Store unopened product at or below 25°C (77°F). Avoid excessive heat and humidity. Use product before the expiration date printed on the label and on the cartridge pouch. Opened cartridges may be stored in the foil pouch protected from light in the refrigerator (2-8°C/36-47°F) for up to 6 months.


How Supplied



Box of 10 × 10 cartridge implants.


Principal Display Panel - 10 X 10 Cartridge Implant Box



Finaplix®-H
(trenbolone acetate)

For Heifers
Fed In Confinement
For Slaughter

Box of 10 x 10 Cartridge Implants

Manufactured by a non-sterilizing process
Restricted Drug (California) - Use only as directed.

MERCK
Animal Health


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