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

Protomor by

Drug Labeling and Warnings

Protomor by is a Animal medication manufactured, distributed, or labeled by Aquarium Muenster Pahlsmeier GmbH, Sigma-Aldrich Production GMBH, Merck KGaA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 activesubstances:

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

- 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86052-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MALACHITE GREEN OXALATE (UNII: GY1H9O33VU) (MALACHITE GREEN CATION - UNII:AWT9R95TV1)	MALACHITE GREEN OXALATE	1.25 mg  in 1 mL
ETHACRIDINE LACTATE (UNII: V5IL571C1T) (ETHACRIDINE - UNII:WIX85M1A6R)	ETHACRIDINE LACTATE	0.10 mg  in 1 mL
METHYLENE BLUE ANHYDROUS (UNII: 8NAP7826UB) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH)	METHYLENE BLUE	0.10 mg  in 1 mL
GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET CATION - UNII:3GVJ31T6YY)	GENTIAN VIOLET	0.05 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86052-010-01	1 in 1 CARTON
1		20 mL in 1 BOTTLE, GLASS
2	NDC: 86052-010-02	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		03/23/2020

Labeler - Aquarium Muenster Pahlsmeier GmbH (317318368)

Establishment
Name	Address	ID/FEI	Business Operations
Sigma-Aldrich Production GMBH		480945463	api manufacture

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