MATRIX- altrenogest solution

Matrix by

Drug Labeling and Warnings

Matrix by is a Animal medication manufactured, distributed, or labeled by Merck Sharp & Dohme Corp., Intervet Production S.A., Aspen Oss B.V., Euroapi France. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

FOR USE IN ANIMALS ONLY

Net Contents: 1000 mL

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Drug Facts:

ACTIVE INGREDIENT

Active ingredients: Altrenogest solution 0.22% (2.2 mg/mL)

INDICATIONS & USAGE

Use: For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle. Treatment with altrenogest solution 0.22% results in estrus (standing heat) 4 to 9 days after completion of the 14-day treatment period.

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Caution: Federal law prohibits extra-label use of this drug to enhance food and/or fiber production in animals.

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Do Not Use: In gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis).

WARNINGS

WARNINGS:

User/Handler Safety:

Keep this and all medication out of the reach of children.

Avoid skin contact. Wear vinyl, neoprene or nitrile protective gloves when handling this product. DO NOT USE LATEX GLOVES Pregnant women or women who suspect they are pregnant should not handle MATRIX® (altrenogest) Solution 0.22%. Women of childbearing age should exercise extreme caution when handling this product. Accidental absorption 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.

People who should not handle this product:

1. Women who are or suspect they are pregnant.
2. Anyone with thrombophlebitis or thromboembolic disorders or with a history of these events.
3. Anyone with cerebral-vascular or coronary-artery disease.
4. Women with known or suspected carcinoma of the breast.
5. People with known or suspected estrogen-dependent neoplasia.
6. Women with undiagnosed vaginal bleeding.
7. People with benign or malignant tumors which developed during the use of oral contraceptives or other estrogen-containing products.
8. Anyone with liver dysfunction or disease.

Accidental exposure: Altrenogest is readily absorbed from contact with the skin. In addition, this oil based product can penetrate porous gloves. Altrenogest should not penetrate intact vinyl, neoprene or nitrile protective gloves; however, if there is leakage (i.e., pinhole, spillage, etc.) the contaminated area covered by such occlusive materials may have increased absorption. DO NOT USE LATEX GLOVES

The following measures are recommended in case of accidental exposure.

Skin Exposure: Wash immediately with soap and water.

Eye Exposure: Immediately flush with plenty of water for 15 minutes. Get medical attention.

If Swallowed: Do not induce vomiting. MATRIX® (altrenogest) Solution 0.22% contains an oil. Call a physician. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. If possible, bring the container and labeling to the physician.

Effects of Overexposure: There has been no human use of this specific product. The information contained in this section is extrapolated from data available on other products of the same pharmacological class that have been used in humans. Effects anticipated are due to the progestational activity of altrenogest. Acute effects after a single exposure are possible; however, continued daily exposure has the potential for more untoward effects such as disruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation of pregnancy and headaches. The oil base may also cause complications if swallowed. In addition, the list of people who should not handle this product is based upon the known effects of progestins used in humans on a chronic basis.

Human Food Safety: Gilts must not be slaughtered for human consumption for 21 days after the last treatment.

Environmental Safety: Place empty drug containers, waste from rinsing the dosing gun, protective gloves or other articles that come in contact with this product in a leak-resistant container for disposal in accordance with applicable Federal, state and local regulations.

Adverse Reactions and Potential Safety Hazards:

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

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When Using This Product: 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.

DOSAGE & ADMINISTRATION

Dosage and Directions: While wearing protective gloves, remove shipping cap and seal; replace with enclosed plastic dispensing cap. Connect the Matrix® Dosing Device to the solution bottle according to the dosing device instructions provided as an attachment to the Matrix® Dosing Device package.

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.

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Other Information:

Storage: 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.

Questions? Comments?

• To report adverse reaction call Merck at 1-800-211-3573
• To obtain product information, including material safety data sheet (MSDS), call 1-800-441-8272.
• For additional information about adverse drug experience for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/Animal/Veterinary/SafetyHealth

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www.merck-animal-health-usa.com

MERCK
Animal Health

NADA 141-222, Approved by FDA

Restricted Drug (California) - use only
as directed.
Not for Human Use

Manufactured for: Intervet Inc
(d/b/a Merck Animal Health),
Summit, NJ 07901
a subsidiary of Merck & Co.

INSTRUCTIONS FOR USE

Dosing Gun (for top dressing of swine feed)
for use with
MATRIX® (altrenogest)

NOZZLE FITTING INSTRUCTIONS

• Connect nozzle and cap to barrel and screw on 7/8 of the way.
• Position nozzle at preferred angle, then tighten cap fully.

Contain any spillage with absorbent materials such as towels. Place empty drug containers, protective gloves or other articles that come in contact with MATRIX® in a leak-resistant container for disposal in accordance with applicable federal, state and local regulations.

OPERATING INSTRUCTIONS

Use vinyl, neoprene or nitrile gloves while using or cleaning the gun and gun parts. DO NOT USE LATEX GLOVES.

• Remove the shipping cap and seal on MATRIX® (altrenogest) bottle. Store the cap in a clean and dry location.
• Apply downward force and fasten the quick connect cap with dip tube onto the product bottle. (The flexible dip tube will contact the bottom of the product bottle and bend slightly)
• Use the black delivery tubing to connect the barbed connectors on the spigot and on the quick–coupling connector.
• Clamp the tubing at the spots shown on the diagram.
  Connect the quick-coupling connector to the quick connect cap.
• Hold the dosing gun vertically with the nozzle on the top. Direct the opening of the nozzle away from any person and cover it with absorbent material. Slowly squeeze and release the handle until air in the barrel is expelled and product starts to come out.
• Prime the gun by expelling two (2) doses of product into a waste container or absorbent material. (Re-prime the gun by expelling two (2) doses if air is observed inside the barrel after switching to a fresh bottle or during dosing period)
• The gun is ready for dosing.
• Store the dosing gun when loaded with product for continued use at or below room temperature, 77 °F ( 25 °C).

CLEANING INSTRUCTIONS

Use vinyl, neoprene or nitrile gloves while using or cleaning the gun and gun parts. DO NOT USE LATEX GLOVES.

• The dosing gun should be disassembled and cleaned following the below instruction after every 14-day dosing period and does not need to be cleaned daily while in use.
• Unscrew the dosing cap and replace shipping cap onto the product bottle to prevent spillage.
• Place the dip tube attached on the quick connect cap into hot soapy water and flush out residual product.
• Flush with clean water. Expel the water by flushing air through.
• Remove the barrel from the dosing gun body and dry the O-ring and felt washer. Apply an adequate amount (2-3 drops) of vegetable oil with a gloved finger to coat the O-ring and felt washer. (DO NOT USE MINERAL OIL)
• Reattach the barrel to dosing gun body and store the whole assembly in a cool and dry place.
• If squeezing the dosing gun handle to dispense product becomes increasingly difficult, the O-ring and felt washer may need to be replaced.

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MERCK
Animal Health

Distributed by:
Intervet Inc.
Summit
NJ 07901

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Carton

MATRIX®
(altrenogest)

SOLUTION 0.22 % (2.2 mg/mL)

For complete product information, see bottle label.
For reliable drug delivery, see the Matrix Dosing
Device instructions for use.

INGREDIENTS AND APPEARANCE

MATRIX 
altrenogest solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 57926-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
altrenogest (UNII: 2U0X0JA2NB) (altrenogest - UNII:2U0X0JA2NB)	altrenogest	2.2 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57926-101-70	1000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141222	09/12/1983

Labeler - Merck Sharp & Dohme Corp. (001317601)