PROTOMOR- malachite green oxalate, ethacridine lactate, methylene blue anhydrous, gentian violet 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.

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Protomor

Information and directions on the use of protomor

Pharmaceutical company and manufacturer
Aquarium Münster Pahlsmeier GmbH
Galgheide 8
D-48291 Telgte (Germany)


Name of the pharmaceutical product
protomor solution

Applications

Medication for ornamental fish against skin parasites, such as Oodinium ocellatum (coral fish disease), Cryptobia, Brooklynella, Trichodina and Cryptocarion. Visible symptoms include pale grey to dark, velvet-like films and barely visible spots which spread to the gills, fins and the entire body as the infection progresses. The gills stick out and the affected fish exhibit an increased breathing rate to the point of respiratory distress.

Types and quantities of active
substances:

1 ml of solution contains:
1.25 mg Malachite green oxalate
0.10 mg Ethacridine lactate monohydrate
0.10 mg Methylthionine chloride
0.05 mg Methylrosaniline chloride

Contraindications and side effects

None known. Should you notice side effects in your ornamental fish, please inform your vet or pharmacist.

Species

Ornamental fish

Dosage and method of administration

protomor has no adverse effects on invertebrates and aquatic plants. Corals and anemones need not be excluded from the treatment. Shake well before use.
Day 1:    Add 40 drops (= 2 ml) of protomor to the aquarium for each 100 l of water and stir to distribute. Do not feed the fish. Switch off protein skimmer and ultraviolet light system. Remove the filter from the aquarium and place it over a container to continue running in order to keep the microorganisms in the filter. Oxygenate the aquarium water. If the water cannot be oxygenated without operating the filter then we recommend running the filter without filtration media in order to ensure sufficient water circulation. In this case keep the filtration media in a container with plenty of aquarium water.
Day 2:    Add 20 drops (= 1 ml) of protomor to the aquarium for each 100 l of water and stir to distribute. Do not feed the fish.
Day 3:    Do not add any medication to the water. Feed the fish as normal. Put the filter and, where applicable, the protein skimmer and ultraviolet light system back into operation. If the filtration media has been stored separately then the water must not be put back in the aquarium. In this case partially wash the filtration media out with lukewarm saltwater (not too thoroughly in order to retain some of the microorganisms) and put back in the filter.
Day 4:    Add 40 drops (= 2 ml) of protomor to the aquarium for each 100 l of water and stir to distribute. Do not feed the fish. Switch off protein skimmer and ultraviolet light system. Remove the filter from the aquarium and place it over a container to continue running in order to keep the microorganisms in the filter. Oxygenate the aquarium water. If the water cannot be oxygenated without operating the filter then we recommend running the filter without filtration media in order to ensure sufficient water circulation. In this case keep the filtration media in a container with plenty of aquarium water.
Day 5:    Do not add any medication to the water. Feed the fish as normal. Put the filter and, where applicable, the protein skimmer and ultraviolet light system back into operation. If the filtration media has been stored separately then the water must not be put back in the aquarium. In this case partially wash the filtration media out with lukewarm saltwater (not too thoroughly in order to retain some of the microorganisms) and put back in the filter.
Day 6:    Do not add any medication to the water. Feed the fish as normal. Replace approx. 30 % of the aquarium water with purified saltwater.

Special precautions for storage

- Keep protomor out of direct light. Store in its original packaging.

- Keep out of reach of children.

Special warnings

- Do not administer to creatures which are used for human consumption.
- The water will change colour due to the active agents but will return to normal again after a few days.
- Do not use after the expiry date.

Special precautions for the disposal of unused pharmaceuticals

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

Product Label

CartonCarton2Instructions

PROTOMOR 
malachite green oxalate, ethacridine lactate, methylene blue anhydrous, gentian violet solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86052-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN CATION - UNII:AWT9R95TV1) MALACHITE GREEN OXALATE1.25 mg  in 1 mL
ETHACRIDINE LACTATE (UNII: V5IL571C1T) (ETHACRIDINE - UNII:WIX85M1A6R) ETHACRIDINE LACTATE0.10 mg  in 1 mL
METHYLENE BLUE ANHYDROUS (UNII: 8NAP7826UB) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE0.10 mg  in 1 mL
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY) GENTIAN VIOLET0.05 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86052-010-011 in 1 CARTON
120 mL in 1 BOTTLE, GLASS
2NDC:86052-010-021 in 1 CARTON
2100 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/23/2020
Labeler - Aquarium Muenster Pahlsmeier GmbH (317318368)
Establishment
NameAddressID/FEIBusiness Operations
Sigma-Aldrich Production GMBH480945463api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Merck KGaA342249299api manufacture

Revised: 3/2020
Document Id: 2a2396bf-5107-44dd-a2b7-102b9baf4b38
Set id: 345606b0-2521-4822-9dcd-054ac7077ea1
Version: 7
Effective Time: 20200324
 
Aquarium Muenster Pahlsmeier GmbH