BACTERIA and FUNGI Aquarium Cure Program Fresh: Product Information

BACTERIA AND FUNGI AQUARIUM CURE PROGRAM FRESH- acriflavine hydrochloride, methyl orange, ethacridine lactate, methylene blue anhydrous
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 : Bacteria & Fungi Fresh

– ACTIVE INGREDIENTS

The vials A and B contain per mL:
• 2.00 mg of 3,6-diamino-10-methylacridinium chloride mixt. with 3,6-diaminoacridine (acriflavine chloride)
• 0.26 mg of 4-(4-dimethylaminophenylazo)-benzenesulfonate sodium salt (methyl orange)
• 4.00 mg of 6,9-diamino-2-ethoxyacridine-DL-lactate monohydrate (ethacridine lactate)
• 2.75 mg of 3,7-bis(dimethylamino)phenazathionium chloride (methylthionine chloride)
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 1.0 mL
• 1 vial of BioDigest Start containing 1.1 mL

– 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 INDICATIONSProduct intended only for the treatment of ornamental freshwater fish. Bacteria & Fungi Fresh has a wide spectrum of action and treats a large number of diseases caused by bacteria or fungi. Visible symptoms may be whitish or yellowish secretions, ulcers, skin inflammations, bleeding, scale loss, fin decomposition, bulging eyes, cotton fluff, swollen belly, or unusual oscillatory movements of the fish. Bacteria & Fungi Fresh can be used when the diagnosis of the disease is neither possible nor obvious.

– 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 fishVial A Do not feed the fishVials AB together
Day 2

Do not feed the fish

Vial B

Do not feed the fishVials A
Day 3 Feed the fishNo Treatment Feed the fishNo Treatment
Day 4 Do not feed the fishVial A Feed the fishNo Treatment
Day 5 Do not feed the fish

Vial B

Feed the fishNo Treatment
Day 6 Feed the fishNo Treatment Feed the fishNo Treatment
Day 7 Do not feed the fishVial A

Do not feed the fish

​Vials AB at the same time

Day 8 Feed the fishNo Treatment Feed the fishNo Treatment
Day 9

Water change: -50% of the volume

Feed the fish

No TreatmentAdd the vial of

BioDigest Start

Water Change:

-30% of the volumeFeed the fish

No Treatment

Add the vial of 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 Bacteria & Fungi 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 water treatment products may decrease the effectiveness of Bacteria & Fungi Fresh. Do not use with another treatment.

– UNWANTED SIDE EFFECTS

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

Keep out of the reach of children.

This veterinary medicines is marketed in accordinance with the Small Animal Exception Scheme

Instructions update 2012-08.

– Special precautions for the disposal of unused pharmaceuticals

Dispose old drugs not entirely used up at the respective collecting points

Disposal advice: after use, vials must be thrown in recyclable glass rubbish

Package Labeling:

box
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caution1
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How To Illustrate
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BACTERIA AND FUNGI AQUARIUM CURE PROGRAM FRESH acriflavine hydrochloride, methyl orange, ethacridine lactate, methylene blue anhydrous kit
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86048-008
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86048-008-01 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 2.0 mL
Part 1 of 2
A VIAL acriflavine hydrochloride, methyl orange, ethacridine lactate, methylene blue anhydrous solution
Product Information
Item Code (Source) NDC:86048-009
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACRIFLAVINE HYDROCHLORIDE (ACRIFLAVINE) ACRIFLAVINE 2.00 mg in 1 mL
METHYL ORANGE (METHYL ORANGE) METHYL ORANGE 0.26 mg in 1 mL
ethacridine lactate (ETHACRIDINE) ethacridine lactate 4.00 mg in 1 mL
METHYLENE BLUE ANHYDROUS (METHYLENE BLUE) METHYLENE BLUE 2.75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86048-009-01 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 acriflavine hydrochloride, methyl orange, ethacridine lactate, methylene blue anhydrous solution
Product Information
Item Code (Source) NDC:86048-014
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACRIFLAVINE HYDROCHLORIDE (ACRIFLAVINE) ACRIFLAVINE HYDROCHLORIDE 2.00 mg in 1 mL
methyl orange (methyl orange) methyl orange 0.26 mg in 1 mL
ethacridine lactate (ETHACRIDINE) ETHACRIDINE 4.00 mg in 1 mL
METHYLENE BLUE ANHYDROUS (METHYLENE BLUE) METHYLENE BLUE 2.75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86048-014-01 1.0 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: 09/2015 Prodibio SAS

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