- SPL UNCLASSIFIED SECTION
- CAUTION
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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 × 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.
Chemical Structure – Deslorelin Acetate
[(6-D-tryptophan-9-(N-ethyl-L-prolinamide)-10-deglycinamide]GnRH
- INDICATIONS
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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 gland disease are being adequately controlled.
Do not use if the foil pouch is damaged.
Remove the luer lock cap from the implanting needle. Attach the actuator syringe to the implanting needle using the luer lock connection. One implant should be implanted 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. If the hair is long, a small section may be clipped if required. Lift the loose skin between the shoulder blades. Insert the entire length of the needle subcutaneously. Fully depress the actuator syringe plunger. Press the skin at the insertion site as the needle is slowly withdrawn, and maintain pressure for 30 seconds. Examine the implanting needle to verify that the implant has not remained within the needle, and that the blue plastic spacer is visible at the tip of the needle. It may be possible to palpate the implant in situ. The biocompatible implant does not require removal. Wash hands after use.
Repeat treatment every 12 months to maintain efficacy. Appropriate endocrine testing and clinical monitoring should be performed at appropriate intervals to monitor the response to therapy.
- CONTRAINDICATIONS
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HUMAN SAFETY WARNINGS
KEEP OUT OF REACH OF CHILDREN. DO NOT HANDLE THIS PRODUCT IF YOU ARE PREGNANT OR NURSING OR SUSPECT YOU MAY BE PREGNANT. Accidental administration may lead to a disruption of the menstrual cycle. Avoid direct skin contact with the implant; if skin contact occurs, wash the affected area immediately with soap and water. The use of gloves is advised. As with all injectable drugs causing profound physiological effects, routine precautions should be employed by practitioners when handling and using Suprelorin® F (4.7 mg) Implant to prevent accidental injection. In case of accidental human injection, a physician should be consulted and the implant should be removed.
- PRECAUTION
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ADVERSE REACTIONS
It is possible that treated ferrets will exhibit signs of soreness and swelling at the implantation site which should resolve over one or two weeks. Undesirable histology at the site of implantation has not been reported in other species (canine). Other reported side effects include: weight gain, lethargy and failure to respond to therapy.
To report suspected adverse drug events, please call Virbac at 1-855-647-3747.
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PHARMACOLOGY
Suprelorin® F (4.7 mg) Implant is a controlled release implant containing the GnRH agonist deslorelin. Deslorelin acetate suppresses the reproductive endocrine system, preventing production of pituitary and gonadal hormones. Deslorelin acetate has not been shown to reduce the size of adrenal tumors and is not considered curative.
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DISPOSAL
Each implanting needle (sterile) is a single use device. Used needles should immediately be placed in a designated and appropriately labeled "sharps" container. Each actuator syringe (non-sterile) is a multi-use device and should be saved for future use with the remaining implant(s) in the carton. Unused implants should be disposed of in accordance with local environmental requirements.
- STORAGE
- HOW SUPPLIED
- INFORMATION FOR OWNERS/CAREGIVERS
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 5 Syringe Carton
Virbac
ANIMAL HEALTHCAUTION: Federal law
restricts this drug to use by
or on the order of a
licensed veterinarian.NOT APPROVED BY FDA - Legally marketed as an FDA
Indexed Product under MIF 900-013.FOR USE IN FERRETS ONLY. Extra-label use is prohibited.
This product is not to be used in animals intended for
use as food for humans or other animals.Suprelorin®F
(DESLORELIN ACETATE)
4.7mg IMPLANTBox contains 5 implants pre-loaded in sterile implanting
needles and 1 non-sterile actuator syringe -
INGREDIENTS AND APPEARANCE
SUPRELORIN F
deslorelin acetate implantProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-444 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength deslorelin acetate (UNII: 679007NR5C) (deslorelin - UNII:TKG3I66TVE) deslorelin acetate 4.7 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51311-444-05 5 in 1 CARTON 1 1 in 1 SYRINGE 2 NDC:51311-444-02 2 in 1 CARTON 2 1 in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES MIF900013 09/12/2012 Labeler - Virbac AH, Inc. (131568396)