Ovaprim

Western Chemical Inc.
Western Chemical Inc.

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. Extra-label use is prohibited.

FULL PRESCRIBING INFORMATION: CONTENTS*

• Ovaprim Label

FULL PRESCRIBING INFORMATION

Note — In order to be legally marketed, an animal drug product intended for minor species must be Approved, 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 on the labeling.

As used on this label, the words “ornamental fish” refer to a wide variety of finfish species maintained primarily for their appearance and do not include any fish that are consumed by humans or food-producing animals.

NET CONTENTS: 10 mL

DESCRIPTION:
Ovaprim® is a liquid peptide preparation that contains an analog of salmon gonadotropin releasing hormone (sGnRHa) and a brain neurotransmitter (dopamine) inhibitor. The sGnRHa in Ovaprim® elicits the release of stored gonadotropins from the pituitary. The dopamine inhibitor (Domperidone) serves to remove other inhibition of GnRH release. Release of stored pituitary gonadotropins may aid spawning by stimulating ovulation and spermiation in sexually mature fish.

CAUTION:
FOR USE IN ORNAMENTAL FINFISH BROODSTOCK ONLY; THIS PRODUCT IS NOT TO BE USED IN
ANIMALS INTENDED FOR USE AS FOOD FOR HUMANS OR OTHER ANIMALS.

WARNING:
Care should be taken to avoid accidental contact or self-injection. In the event of accidental self-injection, seek medical advice immediately. Use in a well ventilated area. Wear gloves, goggles and suitable protective clothing.  Not for use in humans. Keep out of the reach of children.

INHALATION: May be harmful. If breathing becomes difficult, move to fresh air, and contact a physician.
INGESTION: May be harmful. If the person is conscious, wash out mouth with copious amounts of water. Contact a physician.
EYE CONTACT: May be harmful. In case of contact, flush with copious amounts of water for at least 15 minutes.  Assure adequate flushing by separating eyelids with fingers. Contact a physician.
SKIN CONTACT: May be harmful. In case of contact, flush with copious amounts of water for at least 15 minutes.  Remove contaminated clothing and wash before re-using. Contact a physician.
OTHER HEALTH INFORMATION: The toxicological properties of sGnRHa have not been thoroughly investigated. The actions are similar to luteinizing hormone releasing hormone (LHRH, Gonadotropin releasing hormone, GnRH) in humans. LHRH is the key mediator in the liberation of the pituitary gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH). LHRH may modify reproductive ability by influencing plasma gonadotropin levels and concomitantly gonadal steroid levels.
To obtain a Material Safety Data Sheet, call WESTERN CHEMICAL INC. at (360) 384-5898.

STORAGE AND HANDLING:
Store below 25°C and protect from sunlight and sources of heat.

DISPOSAL:
Contact your State Environmental Control Agency, or the Hazardous Waste Representative at the nearest EPA Regional Office for guidance pertaining to disposal of unused product.

QUESTIONS?COMMENTS:
For technical assistance, call Western Chemical Inc. at (360) 384-5898.  To report an adverse event, call WESTERN CHEMICAL INC. at (360) 384-5898, or FDA at 1-888-FDA-VETS.

Ovaprim Label