WORM AND PARASITES AQUARIUM CURE PROGRAM FRESH- praziquantel kit

Worm and Parasites Aquarium Cure Program Fresh by

Drug Labeling and Warnings

Worm and Parasites Aquarium Cure Program Fresh by is a Animal medication manufactured, distributed, or labeled by Prodibio SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INSTRUCTIONS

PRESENTATION

SPL UNCLASSIFIED SECTION

- PRODUCT NAME: Worms & Parasites Fresh

- 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 1	Water 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 2	Water change: - 50% of the volume; Feed the fish; No Treatment	Water change: - 50% of the volume; Feed the fish; No Treatment
Day 3	Feed the fish; No Treatment	Feed the fish; No Treatment
Day 4	Feed the fish; No Treatment	Feed the fish; No Treatment
Day 5	Feed the fish; No Treatment	Feed the fish; No Treatment
Day 6	Feed the fish; No Treatment	Feed the fish; No Treatment
Day 7	Do 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 8	Water change: - 50% of the volume; Feed the fish; No Treatment
Day 9	Water 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.

- UNWANTED SIDE EFFECTS

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

WARNINGS AND PRECAUTIONS

Product for ornamental fish only, do not use with fish intended for consumption.

Keep out of the reach of children.

For animal treatment only

Package Labeling:

INGREDIENTS AND APPEARANCE

WORM AND PARASITES AQUARIUM CURE PROGRAM FRESH 
praziquantel kit

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86048-001

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86048-001-01	1 in 1 BOX

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	3 VIAL, SINGLE-USE	3.9 mL
Part 2	2 VIAL, SINGLE-USE	3 mL

Part 1 of 2

A VIAL 
praziquantel solution

Product Information
Item Code (Source)	NDC: 86048-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)	PRAZIQUANTEL	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86048-002-01	1.3 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/24/2015

Part 2 of 2

B VIAL 
praziquantel solution

Product Information
Item Code (Source)	NDC: 86048-011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)	PRAZIQUANTEL	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86048-011-01	1.5 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/24/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/24/2015

Labeler - Prodibio SAS (647909431)