Animal NDC 86048-003-01 Worm And Parasites Aquarium Cure Program Salt

Praziquantel

Animal Product Information

Field Name Field Value
Animal NDC Code 86048-003-01
Proprietary Name Worm And Parasites Aquarium Cure Program Salt What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Praziquantel What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Prodibio Sas
Product Type Otc Animal Drug
Usage Information
    Shake each vial well before use. Follow this protocol: Aquarium Volume Days 60-100L 101-180L Day 1Water change:- 75% of the volumeDo not feed the fishVials AAA together Water change:- 75% of the volumeDo not feed the fishVials AAABB together Day 2Water change:- 50% of the volumeFeed the fishNo TreatmentWater change:- 50% of the volumeFeed the fishNo Treatment Day 3Feed the fishNo TreatmentFeed the fishNo Treatment Day 4Feed the fishNo TreatmentFeed the fishNo Treatment Day 5Feed the fishNo TreatmentFeed the fishNo Treatment Day 6Feed the fishNo TreatmentFeed the fishNo Treatment Day 7Do not feed the fishVials BB at the same timeFeed the fishWater change:- 50% of the volumeAdd the vial BioDigest Start Day 8Water change:- 50% of the volumeFeed the fishNo Treatment Day 9Water change:- 50% of the volumeFeed the fishNo TreatmentAdd the vial BioDigest StartDuring 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.
Active Ingredient(s)
  • Praziquantel
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • WATER (059QF0KO0R)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • WATER (059QF0KO0R)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • WATER (059QF0KO0R)
  • PROPYLENE GLYCOL (6DC9Q167V3)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Worm And Parasites Aquarium Cure Program Salt Images

Worm And Parasites Aquarium Cure Program Salt Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Instructions




Other



- 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 ([email protected]).


- 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.


Package Labeling:




* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.