Worm and Parasites Aquarium Cure Program Fresh: Product Information

WORM AND PARASITES AQUARIUM CURE PROGRAM FRESH- 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.

INSTRUCTIONS

PRESENTATION

- 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 INDICATIONSProduct 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 volumeDo not feed the fishVials AAA together Water change:- 75% of the volumeDo not feed the fishVials AAABB together
Day 2 Water change:- 50% of the volumeFeed the fishNo Treatment Water change:- 50% of the volumeFeed the fishNo Treatment
Day 3 Feed the fishNo Treatment Feed the fishNo Treatment
Day 4 Feed the fishNo Treatment Feed the fishNo Treatment
Day 5 Feed the fishNo Treatment Feed the fishNo Treatment
Day 6 Feed the fishNo Treatment Feed the fishNo Treatment
Day 7 Do not feed the fishVials BB at the same time Feed the fishWater change:- 50% of the volumeAdd the vial BioDigest Start
Day 8 Water change:- 50% of the volumeFeed the fishNo Treatment
Day 9 Water change:- 50% of the volumeFeed the fishNo TreatmentAdd 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).

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:

box
(click image for full-size original)
caution
(click image for full-size original)

insert
(click image for full-size original)
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 Multilevel Packaging
1 NDC:86048-001-01 1 KIT in 1 BOX None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86048-002-01 1.3 mL in 1 VIAL, SINGLE-USE None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86048-011-01 1.5 mL in 1 VIAL, SINGLE-USE None
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)

Revised: 08/2015 Prodibio SAS

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2020. All Rights Reserved.