OVUGEL- triptorelin acetate gel

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Triptorelin Acetate (UNII: 43OFW291R9) (Triptorelin - UNII:9081Y98W2V)

Disponible desde:

United-AH II, LLC

Designación común internacional (DCI):

Triptorelin Acetate

Composición:

Triptorelin 100 ug in 1 mL

Vía de administración:

VAGINAL

tipo de receta:

OTC

indicaciones terapéuticas:

For the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination.  Not approved for use in gilts.  Safety and effectiveness have not been evaluated in these animals. Use of a bottle mount multi-dose applicator is recommended to ensure accurate dosing. The use of adequate sperm numbers per insemination and proper semen storage, as recommended by the semen or artificial inseminator catheter suppliers, is recommended.

Resumen del producto:

OvuGel is available in 52.5 mL multi-dose bottle (carton of 6).

Estado de Autorización:

New Animal Drug Application

Ficha técnica

OVUGEL- TRIPTORELIN ACETATE GEL
UNITED-AH II, LLC
----------
OVUGEL
ACTIVE INGREDIENT:
triptorelin acetate
DOSAGE FORM & STRENGTH:
100 mcg triptorelin per mL (as triptorelin acetate)
Gel for intravaginal use
INDICATIONS FOR USE:
For the synchronization of time of insemination in weaned sows to
facilitate a single
fixed-time artificial insemination. Not approved for use in gilts.
Safety and effectiveness
have not been evaluated in these animals.
DESCRIPTION:
OvuGel is a thin, clear to slightly hazy gel. Each mL of OvuGel
contains 100 mcg of
triptorelin (as triptorelin acetate) for intravaginal administration.
WARNINGS:
WITHDRAWAL PERIOD:
No withdrawal period is required when used according to labeling.
USER SAFETY WARNINGS:
Not for Use in Humans. Keep Out of Reach of Children. The Material
Safety Data Sheet
(MSDS) contains more detailed occupational safety information.
ANIMAL SAFETY WARNINGS:
OvuGel should not be used in sows with obvious reproductive tract
abnormalities.
RECOMMENDATIONS FOR SAFE AND EFFECTIVE USE:
Use of a bottle mount multi-dose applicator is recommended to ensure
accurate dosing.
The use of adequate sperm numbers per insemination and proper semen
storage, as
recommended by the semen or artificial inseminator catheter suppliers,
is
recommended.
DIRECTIONS FOR USE:
OvuGel should be administered intravaginally at approximately 96 hours
after weaning.
The product should be warmed at room temperature for a minimum of 10
minutes prior
to use. Insert the delivery tube into the vagina so that the tip rests
1/2 inch (1-3 cm)
posterior to the cervix. Use a separate sheath over the delivery tube
for each sow
treated. Each sow should receive a single 2 mL dose of OvuGel. Sows
should be
inseminated 22 +/- 2 hours following administration of OvuGel using
standard artificial
insemination techniques. Sows should be exposed to a boar during time
of
insemination. (See end of package insert for more detailed directions
for OvuGel
administration).
STORAGE, HANDLING, AND DISPOSAL:
Store at refrigerator temperature