DACTYMOR- praziquantel solution

DACTYMOR by

Drug Labeling and Warnings

DACTYMOR by is a Animal medication manufactured, distributed, or labeled by Aquarium Muenster Pahlsmeier GmbH, Alvira Animal Health LTD., Merck KGaA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

- 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

INGREDIENTS AND APPEARANCE

DACTYMOR 
praziquantel solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)	PRAZIQUANTEL	10 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86052-002-01	1 in 1 CARTON
1		20 mL in 1 BOTTLE, GLASS
2	NDC: 86052-002-02	1 in 1 CARTON
2		100 mL in 1 BOTTLE, GLASS

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	Business Operations
Alvira Animal Health LTD.		650916617	api manufacture

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