WORM AND PARASITES AQUARIUM CURE PROGRAM SALT- praziquantel 
Prodibio SAS

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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Worm & Parasites Aquarium Cure Program Salt

INSTRUCTIONS

PRESENTATION

- PRODUCT NAME: Worms & Parasites Salt

- ACTIVE INGREDIENTS

The vials A and B contain per mL:
• 40,00 mg of 2-(Cyclohexylcarbonyl)-1,2,3,6,7-11b-hexahydro-4Hpyrazino(2,1a)-isoquinolin-4-one (praziquantel)
•The BioDigest Start vial contains nitrifying and denitrifying living bacteria that have not been genetically modified.

- EXCIPIENTS

• Purified water
• Propylene glycol

- PHARMACEUTICAL FORM & CONTENTS

• 3 A vials containing 1.3 mL
• 2 B vials containing 1.5 mL
• 1 vial of BioDigest Start containing 1.1 mL

- MANUFACTURER

Vials A and B : product manufactured for PRODIBIO, under Good Manufacture Practices (GMP), by Aquarium Münster Pahlsmeier GmbH, Galgheide 8, D-48291 Telgte, Allemagne

Vial of BioDigest Start : PRODIBIO 3, Allée des Maraîchers, 13013 Marseille France

USAGE

- THERAPEUTIC INDICATIONS
Product intended only for treatment of ornamental freshwater fish infested with skin worms (Gyrodactylus), gill worms (Dactylogyrus), or tapeworms (Cestodes). Visible symptoms are fish rubbing against the scenery (to get rid of the parasites) in the case of Gyrodactylus; increased respiration for Dactylogyrus; and weight loss despite normal food intake for Cestodes.

- DOSAGE AND DIRECTIONS FOR USE

Shake each vial well before use. Follow this protocol:

 Aquarium Volume
 Days 60-100L 101-180L
 Day 1Water change:
- 75% of the volume
Do not feed the fish
Vials AAA together
 Water change:
- 75% of the volume
Do not feed the fish
Vials AAABB together
 Day 2Water change:
- 50% of the volume
Feed the fish
No Treatment
Water change:
- 50% of the volume
Feed the fish
No Treatment
 Day 3Feed the fish
No Treatment
Feed the fish
No Treatment
 Day 4Feed the fish
No Treatment
Feed the fish
No Treatment
 Day 5Feed the fish
No Treatment
Feed the fish
No Treatment
 Day 6Feed the fish
No Treatment
Feed the fish
No Treatment
 Day 7Do not feed the fish
Vials BB at the same time
Feed the fish
Water change:
- 50% of the volume
Add the vial BioDigest Start
 Day 8Water change:
- 50% of the volume
Feed the fish
No Treatment
 Day 9Water change:
- 50% of the volume
Feed the fish
No Treatment
Add the vial BioDigest Start

During the treatment, carefully monitor the aquarium. Ensure a good water flow and a good oxygenation. Indeed, in the presence of a large bacterial population (filter, gravel), the use of Worms & Parasites Fresh can lead to significant bacterial growth which will induce over-consumption of oxygen. If the water becomes cloudy due to a sudden increase in the number of bacteria, or if signs of a lack of oxygen appear, do an immediate water change of 50% of the Aquarium Volume.

- PRESERVATION

Keep the vials in the original packaging away from direct sunlight and heat sources.
Do not use after the expiration date printed on the box and vials.

PRECAUTIONS
- CONTRAINDICATIONS & INTERACTIONS

Invertebrates such as snails and shrimps cannot withstand Worms & Parasites Fresh, and must be removed from the aquarium before beginning the treatment.
Do not use with another treatment.

- UNWANTED SIDE EFFECTS

None known. Should you notice any side effects, please let us know (info@prodibio.fr).

- SPECIAL PRECAUTIONS

Sources of UV radiation and skimmers must be stopped during the treatment.
Product for ornamental fish only, do not use with fish intended for consumption.

Keep out of the reach of children.

Package Labeling:

box

cautioninsert

WORM AND PARASITES AQUARIUM CURE PROGRAM SALT 
praziquantel kit
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86048-003
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86048-003-011 in 1 BOX
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 VIAL, SINGLE-USE 3.9 mL
Part 22 VIAL, SINGLE-USE 3 mL
Part 1 of 2
A VIAL 
praziquantel solution
Product Information
Item Code (Source)NDC:86048-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86048-002-011.3 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/24/2015
Part 2 of 2
B VIAL 
praziquantel solution
Product Information
Item Code (Source)NDC:86048-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86048-011-011.5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/24/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/24/2015
Labeler - Prodibio SAS (647909431)

Revised: 8/2015
Document Id: 239a6d43-ca1d-43b4-9758-fc4da0e16390
Set id: 07ab50bc-3c78-42ca-94ad-85788ad675eb
Version: 2
Effective Time: 20150828
 
Prodibio SAS