Label: DACTYMOR- praziquantel solution

  • NDC Code(s): 86052-002-01, 86052-002-02
  • Packager: Aquarium Muenster Pahlsmeier GmbH
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated March 19, 2020

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  • 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

    CartonCarton2PackageInsert

  • INGREDIENTS AND APPEARANCE
    DACTYMOR 
    praziquantel solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86052-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL10 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86052-002-011 in 1 CARTON
    120 mL in 1 BOTTLE, GLASS
    2NDC:86052-002-021 in 1 CARTON
    2100 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/19/2020
    Labeler - Aquarium Muenster Pahlsmeier GmbH (317318368)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alvira Animal Health LTD.650916617api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Merck KGaA342249299api manufacture