DACTYMOR

Manufacturer
Aquarium Muenster Pahlsmeier GmbH | Alvira Animal Health LTD. | Merck KGaA
Effective date
2024-04-19
Label type
OTC ANIMAL DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:43:01

Label at a glance#

ProductDACTYMOR
Active ingredientPRAZIQUANTEL
Label structure11 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

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

SPL UNCLASSIFIED SECTION

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

INDICATIONS & USAGE SECTION

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:

OTC - ACTIVE INGREDIENT SECTION

1 ml of solution contains:

40 mg of Praziquantel

Contraindications and side effects

CONTRAINDICATIONS SECTION

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

Species

SPL UNCLASSIFIED SECTION

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

Dosage instructions and method of administration

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

- Keep out of reach of children.

Special Warnings

WARNINGS SECTION

- 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.

OTC - DO NOT USE SECTION

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

DISPOSAL AND WASTE HANDLING

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonCarton2Carton2PackageInsertPackageInsert

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PRAZIQUANTEL Pharmacologic Class Indexing3Indexing - Pharmacologic Class20190712

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8cabd598-669e-43ab-9753-4aec00a484cbProduct name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86052-002-01DACTYMOR20 mL in 1 BOTTLE, GLASSSOLUTION208
86052-002-01DACTYMOR1 in 1 CARTONSOLUTION18
86052-002-02DACTYMOR1 in 1 CARTONSOLUTION18
86052-002-02DACTYMOR100 mL in 1 BOTTLE, GLASSSOLUTION1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86052-002DACTYMOR (PRAZIQUANTEL) SOLUTION [AQUARIUM MUENSTER PAHLSMEIER GMBH]84 package rows20240426_3ecf74c2-a024-461a-98d8-3328ea18b587.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PRAZIQUANTELACTIVE INGREDIENT6490C9U4571
PRAZIQUANTELACTIVE MOIETY6490C9U4571

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86052-00286052-002-01, 86052-002-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAZIQUANTEL6490C9U457ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAZIQUANTELPRAZIQUANTELPar Health USA, LLC16f2b9c4-a260-4a31-bd52-e5945913246c2026-08-12Warnings, Adverse reactionsName fallback
generic name: PRAZIQUANTEL
BiltricidePRAZIQUANTELBayer HealthCare Pharmaceuticals Inc.34ce1cdd-648e-4f1e-8512-bf3d4cc22eb92026-03-02Warnings, Adverse reactionsName fallback
generic name: PRAZIQUANTEL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.