Animal NDC 86048-004-01 Spots And Velvets Aquarium Cure Program Fresh
Acriflavine Hydrochloride, Gentian Violet, Malachite Green Oxalate, Methylene Blue
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 86048-004-01 |
| Proprietary Name | Spots And Velvets Aquarium Cure Program Fresh 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 | Acriflavine Hydrochloride, Gentian Violet, Malachite Green Oxalate, Methylene Blue 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 |
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| Active Ingredient(s) |
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| Inactive Ingredient(s) |
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| 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. |
Spots And Velvets Aquarium Cure Program Fresh Images
Spots And Velvets Aquarium Cure Program Fresh 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
- - Active Ingredients
- - Excipients
- - Pharmaceutical Form & Contents
- - Manufacturer
- Usage
- - Dosage And Directions For Use
- - Preservation
- Precautions- Contraindications & Interactions
- - Unwanted Side Effects
- - Special Precautions
- - Special Precautions For The Disposal Of Unused Pharmaceuticals
- Package Labeling:
Instructions
Other
- PRODUCT NAME : Spots & Velvets Fresh
Instructions update 2012-08.
This veterinary medicines is marketed in accordinance with the Small Animal Exception Scheme
- Active Ingredients
The vials A and B contain per mL:
• 0.3 mg of 3,6-Diamino-10-methylacridinium chloride mixt. with 3,6-diaminoacridine (acriflavine chloride)
• 0.5 mg of Hexamethylpararosaniline chloride (crystal violet)
• 1.0 mg of N,N,N',N'-Tetramethyl-4,4'-diaminotriphenylcarbenium oxalate (malachite green oxalate)
• 2.5 mg of 3,7-bis(Dimethylamino)phenazathionium chloride (methylene blue)
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 0.8 mL each
• 2 B vials containing 0.6 mL each
• 1 vial of BioDigest Start containing 1.1 mL each
- Manufacturer
Vials A and B : product manufactured for PRODIBIO,
under GMP, by Aquarium Münster Pahlsmeier GmbH,
Galgheide 8, D-48291 Telgte, GE
Vial of BioDigest Start : PRODIBIO
3, Allée des Maraîchers, 13013 Marseille, France
Usage
- THERAPEUTIC INDICATIONS
Product intended only for the treatment of ornamental fish with the so-called "white spots" and "velvet" diseases, mainly caused by Ichthyophthirius, Oodinium and secondary bacterial infections caused indirectly by these protists. Visible symptoms are white spots, granular lesions or fluffy layers of pale gray. They appear on the gills, fins and may extend to the whole body. Infected fish fins retract and try to remove the parasites by rubbing against the scenery. Those whose gills are very affected have an abnormally high respiratory activity, become apathetic and lose weight quickly.
- Dosage And Directions For Use
Shake each vial well before use. Follow this protocol:
| Days | 60-100L | 101-180L |
| Day 1 | Do not feed the fish Vial A | Do not feed the fish Vials AB together |
| Day 2 | Do not feed the fish Vial A | Do not feed the fish Vials AB together |
| Day 3 | Feed the fish No Treatment | Feed the fish No Treatment |
| Day 4 | Do not feed the fish Vial B | Feed the fish No Treatment |
| Day 5 | Feed the fish No Treatment | Feed the fish No Treatment |
| Day 6 | Do not feed the fish Vial A | Do not feed the fish Vial A |
| Day 7 | Do not feed the fish Vial B | Feed the fish No Treatment |
| Day 8 | Feed the fish No Treatment | Feed the fish No Treatment |
| Day 9 | Feed the fish Water change 50% of the | Feed the fish Water change 30% of the volume Add vial BioDigest Start |
Ensure a good flow and good water oxygenation. To protect the biological filter, during the treatment days, remove the bacterial support material from the filter. Run it in another aquarium if possible, or at least keep it moist with water in a container. Reinsert the support material on the days the fish are fed, after briefly rinsing it with clean water.
- 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 Spots & Velvets Fresh, and must be removed from the aquarium before beginning the treatment.
Some filiform plants can be damaged by the treatment.
The simultaneous use of softened water may decrease the effectiveness of treatment.
Do not use with another treatment.
- Unwanted Side Effects
None known. Should you notice any side effects, please let us know ([email protected]).
The water coloration is due to the active ingredients and will disappear after a few days.
- 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.
- Special Precautions For The Disposal Of Unused Pharmaceuticals
Dispose od drugs not entirely used up at the respective collecting points
Disposal advice: after use, vials must be thrown in recyclable glass rubbish
Package Labeling:
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.