1. Home
  2. Animal Drug Index - M
  3. Matrix

Animal NDC 57926-101-70 Matrix

Altrenogest

Animal Product Information

Field Name Field Value
Animal NDC Code 57926-101-70
Proprietary Name Matrix 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 Altrenogest 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
    Oral solution, 2.2 mg altrenogest per mL (0.22%) Synthetic progestinFor Use in Swine Only
Active Ingredient(s)
  • Altrenogest
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 NADA141222 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.

Matrix Images

Matrix 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



Veterinary Indications



Oral solution, 2.2 mg altrenogest per mL (0.22%) Synthetic progestin

For Use in Swine Only


Uses:



For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle. Treatment with MATRIX® results in estrus (standing heat) 4 to 9 days after completion of the 14-day treatment period.

It is a violation of Federal law to use this drug product other than as directed in the labeling or as directed by your veterinarian.


Description



DESCRIPTION:

MATRIX® (altrenogest) Oral Solution contains 2.2 mg altrenogest per mL (0.22%) in an oil solution.


Warnings:



WITHDRAWAL PERIODS
Animals intended for human consumption must not be slaughtered within 21 days of the last treatment with this drug product.


Other



USER SAFETY WARNINGS:

Not for use in humans. Keep out of reach of children.

Skin contact must be avoided as MATRIX® is readily absorbed through unbroken skin, and exposure may result in serious side effects to both women and men. Always wear vinyl, neoprene, or nitrile protective gloves when handling MATRIX or when in contact with equipment or surfaces contaminated by this product. Latex gloves are not protective.

PREGNANT WOMEN OR WOMEN WHO MAY BE PREGNANT SHOULD NOT HANDLE MATRIX® (altrenogest). WOMEN OF CHILDBEARING AGE SHOULD EXERCISE EXTREME CAUTION WHEN HANDLING THIS PRODUCT.

Accidental absorption, such as absorption through the skin, could lead to a disruption of the menstrual cycle or prolongation of pregnancy. Wash off accidental spillage on the skin immediately with soap and water. Any equipment or surfaces that come in contact with MATRIX® should be adequately cleaned and decontaminated to prevent human exposure.

Always use the MATRIX® Dosing Device to administer this product. The MATRIX® bottle is designed only for use with the MATRIX® Dosing Device. Use without the device increases the risk of human exposure.

PEOPLE WHO SHOULD NOT HANDLE MATRIX®:

Based on known effects of long-term progestin use in humans.

  • Women who are or may be pregnant.
  • Anyone with blood clots or clotting disorders, or with a history of these events.
  • Anyone with a history of heart disease or stroke.
  • Women with known or suspected breast cancer.
  • People with known or suspected estrogen-dependent cancer.
  • Women with vaginal bleeding of unknown cause.
  • People with tumors which developed during the use of oral contraceptives or other estrogen-containing products.
  • Anyone with liver dysfunction or disease.

    • ACCIDENTAL EXPOSURE:

    MATRIX® is readily absorbed from contact with the skin. In addition, this oil-based product can penetrate latex or other types of porous gloves. Always wear vinyl, neoprene, or nitrile protective gloves when handling MATRIX®. Latex gloves are not protective. If MATRIX®  gets inside gloves by damage or spilling, the covered skin may absorb more of the drug. Side effects after a single exposure are possible; however, continued daily exposure has the potential for more serious effects.

    IN CASE OF ACCIDENTAL EXPOSURE:

    Skin exposure and/or clothing contamination: Wash skin immediately with soap and water, and launder clothing with detergent.

    Eye exposure: Immediately flush with plenty of water for 15 minutes. Get medical attention. If wearing contact lenses, flush eyes immediately with water before removing lenses.

    If swallowed: Do not induce vomiting. Seek medical attention immediately. MATRIX® contains an oil. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. If possible, bring the labeling to the physician.

    Reported HUMAN Effects from Exposure:

    Side effects have been reported in women and men following accidental exposure to altrenogest products, including MATRIX®, either through handling of the product or contact with contaminated surfaces.

    • Reproductive side effects reported in women included abnormal or absent menstrual cycles.
    • Reproductive side effects in men included decreased libido.
    • Other side effects reported in women and men included headaches, fever, abdominal pain, nausea, diarrhea, vomiting, and rashes.

      • Approved by FDA under NADA # 141-222

      Restricted Drug (California) - use only as directed.

      Manufactured for: Intervet Inc.
      (d/b/a Merck Animal Health), Rahway,
      NJ 07065, a subsidiary of Merck & Co.

      Made in France.
      Rev. 08/2023


Animal Safety Warnings:



Do not use MATRIX® in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute, or chronic endometritis).

Underdosing of MATRIX® may lead to the occurrence of cystic follicles.


Other Effects You May Notice:



A small percentage (less than 5%) of treated gilts may exhibit estrus (standing heat) during the 14-day treatment period. Gilts nearing estrus at the start of the 14-day treatment period may express estrus early in that period.


Directions:



While wearing vinyl, neoprene, or nitrile gloves, remove shipping cap and seal; replace with enclosed plastic dispensing cap. This product can penetrate latex or other types of porous gloves. Latex gloves are not protective. Connect the MATRIX® Dosing Device to the solution bottle, according to the instructions provided with the MATRIX® Dosing Device package. Do not use any dosing device other than the MATRIX® Dosing Device.

Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days. Treat gilts on an individual animal basis by top-dressing MATRIX® on a portion of each gilt's daily feed allowance. To produce the desired synchronization of estrus in a group of gilts, treat all of the gilts daily for the same 14-day period.


How Supplied:



MATRIX® (altrenogest) Oral Solution contains 2.2 mg/mL (0.22%) of the active ingredient, packaged in 1,000 mL plastic bottles.


Storage, Handling, And Disposal:



Store MATRIX® solution bottle and Dosing Device when loaded with solution for continued use at or below room temperature, 77°F (25°C). Close tightly. Refer to the MATRIX® Dosing Device label for equipment cleaning instructions. Place empty drug containers, waste from rinsing the Dosing Device, protective gloves, or other articles that contact this product in a leak-resistant container for disposal in accordance with applicable Federal, state, and local regulations.


Questions? Comments?



  • To report side effects, contact Merck at 1-800-211-3573, or online at www.merck-animal-health-usa.com
  • To obtain product information, including a safety data sheet (SDS), call 1-800-441-8272.
  • For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or online at: www.fda.gov/reportanimalae

Principal Display Panel - 1000 Ml Bottle Carton



MATRIX®
(altrenogest)

Oral Solution, 2.2 mg altrenogest per mL (0.22%)

FOR USE IN SWINE ONLY

  • Before using this drug, read package insert for
    complete product information.
  • Always use the MATRIX® Dosing Device to
    administer this product.

    • It is a violation of Federal law to use this drug product other
    than as directed in the labeling or as directed by your
    veterinarian.


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