SUPRELORIN F- deslorelin acetate implant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

deslorelin acetate (UNII: 679007NR5C) (deslorelin - UNII:TKG3I66TVE)

Available from:

Virbac AH, Inc.

INN (International Name):

deslorelin acetate

Composition:

deslorelin acetate 4.7 mg

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Suprelorin® F (4.7 mg) Implant is indicated for the management of adrenal gland cortical disease in the male and female domestic ferret. Do not use this product in ferrets with known hypersensitivity to deslorelin acetate or other synthetic hormones.

Product summary:

Five (5) or two (2) implants pre-loaded in implanting needles and individually packaged per carton. For technical assistance, to request an SDS, or to report suspected adverse drug events, please call Virbac at 1-800-338-3659.

Authorization status:

Legally Marketed Unapproved New Animal Drugs for Minor Species

Summary of Product characteristics

SUPRELORIN F- DESLORELIN ACETATE IMPLANT
VIRBAC AH, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
SUPRELORIN F
(DESLORELIN ACETATE) 4.7 MG IMPLANT
LEGAL STATUS - IN ORDER TO BE LEGALLY MARKETED, A NEW ANIMAL DRUG
INTENDED
FOR A MINOR SPECIES MUST BE APPROVED, CONDITIONALLY
APPROVED, OR INDEXED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT
IS INDEXED - MIF # 900-013. EXTRA-LABEL USE IS PROHIBITED. FOR USE IN
FERRETS ONLY THIS PRODUCT IS NOT TO BE USED IN ANIMALS INTENDED FOR
USE AS
FOOD FOR HUMANS OR FOOD-PRODUCING ANIMALS.
CAUTION
FEDERAL (USA) LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A
LICENSED
VETERINARIAN.
DESCRIPTION
Suprelorin® F (4.7 mg) Implant is a synthetic GnRH analogue
(deslorelin acetate) in a
biocompatible, slow release subcutaneous implant. The implant is a
solid, opaque, white
to pale yellow cylinder, 2.3 mm x 12.5 mm in length and weighing 50
mg. The
Suprelorin® F (4.7 mg) Implant comes pre-loaded in an implanting
needle. Each implant
contains 4.7 mg deslorelin (as deslorelin acetate) in an inert matrix.
INDICATIONS
SUPRELORIN® F (4.7 mg) Implant is indicated for the management of
adrenal gland
cortical disease in the male and female domestic ferret.
DOSAGE AND ADMINISTRATION
®
THE RECOMMENDED DOSAGE IS ONE, 4.7 MG IMPLANT PER FERRET EVERY 12
MONTHS. APPROPRIATE CLINICAL MONITORING IS SUGGESTED TO DETERMINE THAT
THE
SYMPTOMS OF ADRENAL DISEASE ARE BEING ADEQUATELY CONTROLLED.
Do not use if the foil pouch is damaged.
Remove Luer Lock cap from the implanting needle. Attach the actuator
syringe to the
implanter using the luer lock connection. One implant should be
implanting needle
subcutaneously at the dorsal aspect of the base of the neck.
Administer only one
implant per ferret. Select the implant site by locating the area of
the back midway
between the shoulder blades. It is not necessary to prepare the
implantation site.