Prazi-Med Product Insert
PRAZI-MED™
(praziquantel)
98.5% Soluble Powder
For Immersion (Bath) Use in Ornamental Finfish Only
PRAZI-MED™ SOLUBLE POWDER IS INDEXED UNDER MIF 900-054. 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 & Drug Administration.
EXTRA-LABEL USE IS PROHIBITED. FOR USE IN ORNAMENTAL FINFISH ONLY. NOT FOR USE IN FISH (ADULTS OR OFFSPRING) INTENDED FOR HUMAN OR ANIMAL CONSUMPTION.
It is a violation of federal law to use this product in a manner other than directed in the labeling.
INDICATIONS: PRAZI-MED™(praziquantel) is indicated for the treatment of internal and external parasites including trematodes (flukes) and cestodes (tapeworms) in ornamental finfish (except Callichthyidae and Cleridae catfish).
DESCRIPTION: PRAZI-MED™ is a white, slightly soluble crystalline powder that contains the anti-cestode and anti-trematode compound, praziquantel. Praziquantel’s mechanism of action is believed to be related to disruption of calcium homeostasis through interaction with voltage-gated calcium (Ca2+) channels within cells of the tegument of susceptible parasites (Baser et. al., 2018).
WARNINGS:
USER SAFETY WARNINGS: Not for use in humans. Keep out of reach of children. Use in well- ventilated area and avoid inhalation. Avoid dust formation. Wear eye protection, dust mask, and chemical-resistant gloves when handling the drug. Avoid contact with skin, eyes, or clothing. Wash thoroughly with soap and water after handling, and before eating, drinking, chewing gum, using tobacco products, or using the toilet.
INHALATION: If inhaled and breathing becomes difficult, move victim to fresh air. Seek medical attention.
ANIMAL SAFETY WARNINGS:
Some fish species may have increased sensitivity to the drug. Due to species sensitivity, do not use PRAZI-MED™ in catfish species of the Callichthyidae and Cleridae families. When fish species sensitivity levels are unknown, shorter duration of application is recommended. Ensure adequate aeration during treatment. Use the product with caution when dosing aquarium systems containing freshwater or marine invertebrate species or plants. The effectiveness of PRAZI-MED™ may vary depending on water conditions (pH, temperature, etc.), duration of treatment, and life stage/life cycle of the target parasite species.
ADDITIONAL RECOMMENDATIONS:
Handle in accordance with good hygiene and safe practices. Keep product and empty container away from heat and sources of ignition.
DIRECTIONS FOR USE:
PRAZI-MED™ is intended for use in personal home aquariums, personal home ponds, or public aquariums and zoos. Not for use in commercial ornamental fish operations. PRAZI-MED™ is packaged as a soluble powder and must be mixed with water prior to use to create an aqueous solution. Before treatment, remove activated carbon from the system. Prior to use, always test the dosage on a small group of fish in a separate tank to ensure fish in the treatment tank can tolerate the dose, since some species of ornamental fish may be more sensitive to praziquantel than others. Calculate the amount of PRAZI-MED™ powder needed to achieve the desired concentration of
2.7 mg/L (10.2 mg/gallon) in the volume of water treated (see Dose Calculation section). Add the measured mount of PRAZI-MED™ to a small, closed container of source or purified water and shake vigorously to form a uniform solution. Pour this solution into the tank in an area of high water flow. Maintain aeration and water flow during treatment.
Dosage: 2.7 mg/L (10.2 mg/gallon) of water.
Immersion treatment can last anywhere from 2 to 24 hours. Two doses of PRAZI-MED™ are required for a full course of treatment. Make a stock solution according to the dosing table by adding the appropriate amount of PRAZl-MED™ to at least 2 liters (more for larger tanks/ponds) of source or purified water and mix vigorously to dissolve. Visible particles in the solution will not affect its effectiveness. Then, slowly pour the mixed solution into the tank or pond in an area of high flow. After 7 days, repeat treatment. Do not conduct water changes during the treatment period. At the end of the treatment period, add chemical filtration and/or activated carbon to the system and wait 24 hours before conducting a 20% water change. See DISPOSAL for additional details on how to manage treated effluent. Do not discharge directly into surface waters.
It’s recommended to quarantine and treat new fish in a separate tank, before adding them to the main tank to limit the spread of parasites and disease. Monitor the tank inhabitants for abnormal behavior or adverse events during the entire treatment period. If abnormal behavior or adverse events are observed in the tank inhabitants, discontinue treatment, conduct a 20% water change, and add carbon or chemical filtration to the system.
To calculate pond size: Length (feet) x Width (feet) x Average Depth (feet) x 7.48 = US gallons.
DOSE CALCULATION:
1 gram PRAZI-MED™ treats 100 gallons (378 L).
(1) Retail Packaging
(a) 10 g Mylar packet + 250 mg scoop
Active ingredient: 10 grams of praziquantel per packet.
Each 10g packet contains enough praziquantel to treat 1,000 gallons (3,780 L) of water. Each 250 mg scoop treats 25 gallons (95 L) of water.
Using the enclosed scoop, determine amount of PRAZI-MED™ needed for a single treatment using the following dosing table:
Dosing Table (10g Packet)
|
Water Volume (Gallons) |
# of Scoops |
|
12.5 |
½ |
|
25 |
1 |
|
50 |
2 |
|
75 |
3 |
|
2 |
4 |
|
250 |
10 |
|
500 |
20 |
|
750 |
30 |
|
1,000 |
40 |
For water volumes <1,000 gallons (3,780 L), use the 50g bottle.
(b) 50 g Bottle + 1g scoop
Active ingredient: 50g of praziquantel per bottle.
Each 50 g bottle contains enough praziquantel to treat 5,000 gallons (18,900 L) of water. Each 1g scoop treats 100 gallons (378 L) of water.
Using the enclosed scoop, determine the amount of PRAZI-MED™ needed for a single treatment using the following table:
Dosing Table (50g Bottle)
|
Water Volume (Gallons) |
# of Scoops |
|
50 |
½ |
|
100 |
1 |
|
250 |
2.5 |
|
500 |
5 |
|
750 |
7.5 |
|
1,000 |
10 |
|
2,500 |
25 |
|
5,000 |
50 |
|
10,000 |
100 |
(2) Commercial Packaging
(a) 250g Bottle (no scoop)
Active Ingredient: 250g of praziquantel per bottle.
Each 250g bottle contains enough praziquantel to treat 25,000 gallons (94,500 L).
Measure the appropriate amount of PRAZI-MED™ needed for a single treatment using the following dosing table:
Dosing Table (250g Bottle)
|
Water Volume (Gallons) |
Weight (Grams) |
|
50 |
½ |
|
100 |
1 |
|
250 |
2.5 |
|
500 |
5 |
|
750 |
7.5 |
|
1,000 |
10 |
|
2,500 |
25 |
|
5,000 |
50 |
|
7,500 |
75 |
|
10,000 |
100 |
|
25,000 |
250 |
HOW SUPPLIED: 10 grams, 50 grams, 250 grams.
STORAGE, HANDLING AND DISPOSAL:
Store at or below 25°C (77°F) and protect from light. Keep product and empty container away from heat and sources of ignition.
Do not conduct water changes during the treatment period. Prior to conducting a water change, subject treated water to chemical filtration for at least 24 hours prior to discharge to remove residual drug. Dispose of unused product, spills, and treated water in a manner that will not lead to contamination of surface water. 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?
To report side effects, for technical assistance or to request an SDS, contact AQION at 1-719-256-0044. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
Manufactured for: Aqion LLC, Dallas, TX 75208 U.S.A.
PRAZI-MED™ is a trademark of Aqion LLC.
© 2025 Aqion LLC. All rights reserved. Rev. 04/2025