DACTYMOR: Product Information

DACTYMOR- praziquantel solution
Aquarium Muenster Pahlsmeier GmbH

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.

Information and directions on the use of dactymor (active agent: praziquantel)

Pharmaceutical company and manufacturer
Aquarium Münster Pahlsmeier GmbH
Galgheide 8
D-48291 Telgte
Germany
Name of the pharmaceutical product
dactymor solution (active agent: praziquantel)

Applications

Treatment against skin worms (Gyrodactylus), trematodes (Dactylogyrus) and tapeworms (Cestodes) in ornamental fish of the orders Cypriniformes, Perch, Catfish and live bearers in fresh water and marine water. Trematode infestation results in an increased respiratory rate. Ornamental fish with tapeworms frequently lose weight rapidly despite normal eating habits. Skin worm infestation will cause fish to attempt to rid themselves of the parasites by scraping.

Types and quantities of active substances:

1 ml of solution contains:

40 mg of Praziquantel

Contraindications and side effects

No known contraindications or side effects. Should you notice side effects in your ornamental fish, please inform your vet or pharmacist.

Species

Ornamental fish of the orders Cypriniformes, perch, catfish and live bearers

Dosage instructions and method of administration

Replace 3/4 of the aquarium water prior to beginning treatment with dactymor. Add 5 ml (= 100 drops) of dactymor for every 100 l of aquarium water and stir the aquarium water to disperse the product. Switch off UV-lamps. After 6 hours treatment a replacement of minimum 3/4 of the aquarium water is required. On the following day change half of the aquarium water. A single treatment is generally adequate for skin worms and tapeworms. However, trematode eggs are not affected. Therefore, when treating trematodes, the treatment should be repeated twice, waiting approx. one week between each treatment (for coldwater ornamental fish, wait approx. one-and-one-half weeks between treatments).
The aquarium should be continuously monitored during the treatment with dactymor. In aquariums containing a large biomass (microorganisms in filters, ground, etc.) the use of dactymor may result in an increase in bacterial growth. In turn this can lead to an oxygen depletion. Immediately change the aquarium water if signs of bacterial turbidity or indications of oxygen depletion are observed.

Special precautions for storage

- Protect dactymor from light. Store in its original packaging.

- Keep out of reach of children.

Special Warnings

- dactymor is unsuitable for invertebrates. Snails, mussels, shrimps, etc. must be excluded from the treatment.
- For ornamental fish of the orders Cypriniformes, perch, catfish and live bearers. Do not use on creatures which are used to obtain food.
- Do not use after the expiry date.

For veterinary use. Do not administer to animals that are for human consumption. Do not use after the expiry date. Protect dactymor from light. Store in the original package.

Special precautions for the disposal of unused pharmaceuticals

Take unused medical products and unfinished containers of medical products to the designated collection points.

Date of last revision of package insert
2012-12-20

product labling

DACTYMOR praziquantel solution

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86052-002 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 10 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:86052-002-01 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS 1 20 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (86052-002-01) 2 NDC:86052-002-02 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS 2 100 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (86052-002-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/19/2020

Labeler — Aquarium Muenster Pahlsmeier GmbH (317318368)

Establishment
Name	Address	ID/FEI	Operations
Alvira Animal Health LTD.		650916617	api manufacture

Establishment
Name	Address	ID/FEI	Operations
Merck KGaA		342249299	api manufacture

Revised: 03/2020 Aquarium Muenster Pahlsmeier GmbH