MATRIX- altrenogest solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Αγόρασέ το τώρα

Κατεβάστε Αρχείο Π.Χ.Π. (SPC)
15-11-2023

Δραστική ουσία:

ALTRENOGEST (UNII: 2U0X0JA2NB) (ALTRENOGEST - UNII:2U0X0JA2NB)

Διαθέσιμο από:

Merck Sharp & Dohme Corp.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

OTC

Θεραπευτικές ενδείξεις:

Oral solution, 2.2 mg altrenogest per mL (0.22%) Synthetic progestin For Use in Swine Only 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.

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

New Animal Drug Application

Αρχείο Π.Χ.Π.

                                MATRIX- ALTRENOGEST SOLUTION
MERCK SHARP & DOHME CORP.
----------
MATRIX (ALTRENOGEST)
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:
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.
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 :
®
®
®
®
®
®
®
®
®
® 1
1. Women who are or may be pregnant.
2. Anyone w
                                
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