MATRIX® (altrenogest)
Net
Contents:
1000 mL
Drug
Facts:
Active
ingredients:
Altrenogest solution 0.22% (2.2 mg/mL)
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.
Caution:
Federal law prohibits extra-label use of this drug to enhance
food and/or fiber production in animals.
Do
Not Use: In gilts having a previous or current history
of uterine inflammation (i.e., acute, subacute or chronic
endometritis).
WARNINGS:
User/Handler
Safety: Keep this and all medication out of the reach
of children.
Avoid skin contact.
Wear vinyl, polyethylene, neoprene, butyl or nitrile protective
gloves when handling this product. 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:
- Women who are or suspect they are pregnant.
- Anyone with thrombophlebitis or thromboembolic
disorders or with a history of these events.
- Anyone with cerebral-vascular or coronary-artery
disease.
- Women with known or suspected carcinoma
of the breast.
- People with known or suspected estrogen-dependent
neoplasia.
- Women with undiagnosed vaginal bleeding.
- People with benign or malignant tumors
which developed during the use of oral contraceptives or
other estrogen containing products.
- 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, polyethylene, neoprene, butyl 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.
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.
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Human Food
Safety: Gilts must not
be slaughtered for human consumption
for 21 days after the last treatment. |
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Environmental
Safety: Place empty drug containers and used syringes,
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.
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 and Directions:
While wearing protective gloves, remove shipping cap and
seal; replace with enclosed plastic dispensing cap. Remove
cover from bottle dispensing tip and connect luer lock syringe
(without needle). Draw out appropriate volume of MATRIX® solution. (Note: Do not remove syringe while bottle is inverted
as spillage may result.) Detach syringe and replace cover
on bottle dispensing tip to prevent leakage. 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. Excessive use of a syringe may cause the syringe to
stick; therefore, replace syringe as necessary.
Other Information: Storage:
Store at or below room temperature, 77ºF (25ºC).
Close tightly.
Questions? Comments?
- To report a suspected adverse reaction,
call 1-800-548-2423.
- To obtain product information, including
material safety data sheet (MSDS), call 1-800-441-8272.
Manufactured
by: DPT Laboratories, Inc., San Antonio, TX 78215
Distributed
by: Intervet Inc., Millsboro, DE 19966.
NADA
141-222, Approved by FDA.
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