Microsoft word - ovaprim insert 02-10-09.doc

Ovaprim® Injectable Solution
(Salmon Gonadotropin Releasing Hormone Analog 20 μg/ml + Domperidone 10 mg/ml)
For intraperitoneal or intramuscular injection in ornamental finfish broodstock only.
Not for use in fish intended for human or animal consumption.
Not for use in fish whose offspring may be consumed by humans or food-producing animals.
NOT APPROVED BY FDA – Legally marketed as an FDA Indexed Product under MIF 900-001.
Note---In order to be legally marketed, an animal drug product intended for a minor species Conditionally Approved, or Indexed by the FDA. THIS PRODUCT IS INDEXED.
It is a violation of Federal law to use this product in a manner other than as directed As used on this label, the words “ornamental fish” refer to a wide variety of finfish their appearance and do not include any fish that are consumed by humans or NET CONTENTS: 10 ml
DESCRIPTION: Ovaprim® is a liquid peptide preparation that contains
hormone (sGnRHa) and a brain neurotransmitter (dopamine) inhibitor.
of stored gonadotropins from the pituitary. The dopamine inhibitor of GnRH release. Release of stored pituitary gonadotropins may spermiation in sexually mature fish.
INDICATION: For intraperitoneal or intramuscular use as
CAUTION:
FOR USE IN ORNAMENTAL FINFISH BROODSTOCK
DSTOCK ONLY;
ONLY THIS PRODUCT
IS NOT TO BE USED IN
ANIMALS INTENDED FOR USE AS FOOD FOR HUM
WARNING:
Care should be taken to avoid accidental
In the event of accidental self-injection, seek goggles and suitable protective clothing.
INHALATION: May be harmful.l If breathin
move to fresh air, and contact a physician.
INGESTION: May be harmful.
ous wash out mouth with copious amounts of water. Contact a EYE CONTACT: May
flush with copious amounts of water for at least 15 minutes.
SKIN CONTAC
o contact, flush with copious amounts of water for at least 15 minutes.
ash before re-using. Contact a physician.
OTHER HEAL
TH INFORMA
NFORM TION:
INFORMAT
A ION: The
Th toxicological properties of sGnRHa have not been thoroughly investigated.
uteinizing hormone releasing hormone (LHRH, Gonadotropin releasing hormone, GnRH) in ato in the liberation of the pituitary gonadotropins, luteinizing hormone (LH) and LHRH may modify reproductive ability by influencing plasma gonadotropin levels To obtain a Material Safety Data Sheet, call WESTERN CHEMICAL INC. at (360) 384-5898.
DIRECTIONS FOR USE:
Ovaprim® is packaged ready for use in liquid form. Precise amounts for individual injections should be withdrawndirectly from the bottle into a syringe. Due to the viscosity of the product, use of syringes with Luer Lock tips orpermanently attached needles is strongly recommended. Use of syringes with slip tips is not recommended sinceneedles could inadvertently eject under pressure.
CLEANLINESS: Syringes/needles should be sterile prior to use.
LOADING: Withdraw only enough solution from the bottle of Ovaprim® Injectable Solution as will be required for theweight of the fish. With the needle pointed upward and directed away from your face, squeeze the syringe gently toexpel any trapped air.
INJECTION: Hold the fish firmly and insert the needle into the abdominal cavity/belly between the pelvic fin and thevent or into the muscle on either side of the dorsal fin. For intra-abdominal injection in smaller species, it may behelpful to secure the fish on a soft wet surface such as a sponge, and to place the fish on its side and inject into therear abdominal cavity to avoid contact with internal organs. Inject Ovaprim® carefully. After injection, gently place thefish into a container of clean aerated water.
SEDATION FOR HANDLING AND RECOVERY: If necessary, sedate broodstock prior to A general dose of Ovaprim® is 0.5 ml per kilogram of bodyweight. This dose may physiological state of individual animals. Environment and temperature also pla process and may affect dose and timing. For most species, only a single dose of of fish with a single dose of Ovaprim® is only effective in fish that are within For other species, a split dose may be needed. For split dosing, a load injected, followed by injection of the remaining 90% of the total dose ovulation may occur in as little as 4 hours post treatment, so fish shou ovulation/spermiation may include a noticeable swelling and “softenin water; the ability to easily express eggs from the female and milt from same tank, onset of spawning behavior (e.g., males “chasin interval between treatment and the onset of ovulation is var should be disturbed as little as possible to reduce stress periods of time than females of the same species.
The dose is calculated based on the weight of of the needle into the fish may be helpful, and use of a tuberculin or in small fish and to minimize trauma at the injection site.
the injection site. Swelling, ulceration, whiteness, redness, or STORAGE and HANDLING:
ANDLING:
DISPOSAL:
ental Control Agency, or the Hazardous Waste Representative at the nearest EPA per ining to disposal of unused product.
QUESTIONS/COMMENTS?
MENTS? For technical assistance, call Western Chemical Inc. at (360) 384-5898. To report an
N CHEMICAL INC. at (360) 384-5898, or FDA at 1-888-FDA-VETS.
Western Chemical Inc.
1269 Lattimore RoadFerndale, WA 98248 An AQUATIC LIFE SCIENCES Company

Source: http://www.wchemical.com/downloads/dl/file/id/41/ovaprim_package_insert.pdf