FANATREX  - gabapentin   
Fusion Pharmaceuticals LLC

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FANATREX

DESCRIPTION

NDC 43093-105-01

Rx only

FusePaq™

FANATREX™

(gabapentin 25 mg/mL, in oral suspension - kit)


FusePaq™ kits provide a convenient approach to rapidly prepare prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practices (cGMP).


Description:


This kit contains active and inactive bulk materials to prepare 420 mL of a gabapentin oral suspension containing 25 mg/mL gabapentin.  This kit may only be used for the extemporaneous mixing of these ingredients by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient.


Contents:

• 10.5 g gabapentin, USP
• 420 mL oral suspension vehicle (water, banana flavor, N-acetyl-D-glucosamine, strawberry flavor, marshmallow flavor, glycerin, stevia powder, acesulfame potassium, xanthan gum, monoammonium glycyrrhizinate, sodium saccharin, sodium benzoate, potassium sorbate, dibasic sodium phosphate)
• Disposable funnel
• Press-in bottle adaptor for oral dispenser
• Oral dispenser
• Instructions

SUGGESTED PREPARATION

Suggested Preparation
Gabapentin, 25 mg/mL oral suspension

1    Remove and Inspect the Contents of the Kit

Remove kit contents. Ensure that seals are present and intact on the gabapentin and oral suspension vehicle bottles. If the seals are not intact, do not use the kit.

2    Prepare for Mixing

Wear gloves and eye protection during mixing operations. Remove the seal from the oral suspension bottle. Break the seal and remove the cap from the gabapentin bottle.

3    Transfer Gabapentin to the Suspension Bottle

Uncap the suspension bottle. Using the included funnel, carefully transfer the gabapentin powder to the suspension bottle. Cap the suspension bottle and mix thoroughly by inverting and shaking until all contents are dissolved. Uncap the suspension bottle. Pour a small amount of the mixed suspension back into the gabapentin bottle. Cap the gabapentin bottle and shake to ensure that all residual gabapentin has been dissolved. Pour the liquid through the funnel into the suspension bottle. Discard the funnel and gabapentin powder bottle.

4    Complete the Mixing Process

Insert the press-in bottle adaptor into the suspension bottle. Recap the suspension bottle. Mix well by inverting repeatedly several times. Visually ensure that all contents are dissolved.

5    Re-label the Suspension

Label the mixed suspension as required for prescription products. Ensure that the original oral suspension vehicle label is removed or obscured, since the original label is no longer accurate once the suspension is prepared.

Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the mixed suspension between 15-30°C (59-86°F). The mixed suspension is stable for at least eight weeks, based upon real-time and accelerated stability studies.

Each lot of suspension vehicle is tested to meet microbial limits per USP Microbial Limit Test <61>. In addition, the suspension vehicle formulation has passed the USP <51> Antimicrobial Effectiveness Test.

An oral dispenser is provided in the kit and may be used to facilitate delivery of the suspension.

U.S. Patents Pending

Manufactured by:
Fusion Pharmaceuticals, LLC
768 Calle Plano
Camarillo, CA 93012

CS75-A1 rev 0

DRUG BOTTLE LABEL

Do not use if safety seal is broken

Gabapentin
1-(Aminomethyl)cyclohexaneacetic acid
CAS #60142-96-3
CAUTION: For manufacturing, processing, repacking, or prescription compounding

Net contents: 10.5 g

Repackaged by Fusion Pharmaceuticals, LLC
Camarillo, CA 93012

CS73-A1 rev 0

SUSPENSION BOTTLE LABEL

Do not use if safety seal is broken
For Prescription Compounding Only

Oral Suspension Vehicle
Dye and paraben free

Ingredients: water, banana flavor, N-acetyl-D-glucosamine, strawberry flavor, marshmallow flavor, glycerin, stevia powder, acesulfame potassium, xanthan gum, monoammonium glycyrrhizinate, sodium saccharin, potassium sorbate, sodium benzoate, dibasic sodium phosphate

Net Contents: 420 mL (14.2 fl oz)

Manufactured for:
Fusion Pharmaceuticals, LLC
Camarillo, CA 93012

CS74-A1 rev 0

Carton Box Label

Do not use if safety seal is broken

NDC 43093-105-01

Rx only

FusePaq™  Kit for Oral Suspension
Fanatrex™
(gabapentin 25 mg/mL, in oral suspension - kit)


Description:
This kit contains active and inactive bulk materials to prepare 420 mL of a gabapentin oral suspension containing 25 mg/mL gabapentin. This kit may only be used for the extemporaneous mixing of these ingredients by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient.

Active Ingredient:

• 10.5 g gabapentin, USP

Inactive Ingredients:

• 420 mL oral suspension vehicle (water, banana flavor, N-acetyl-D-glucosamine, strawberry flavor, marshmallow flavor, glycerin, stevia powder, acesulfame potassium, xanthan gum, monoammonium glycyrrhizinate, sodium saccharin, potassium sorbate, sodium benzoate, dibasic sodium phosphate)
• Disposable funnel
• Press-in bottle adaptor for oral dispenser
• Oral dispenser
• Instructions

CAUTION: For manufacturing, processing, repacking, or presciption compounding. Federal law prohibits dispensing without prescription.

U.S. Patents Pending

CS72-A1 rev 0

FANATREX  gabapentin   kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43093-105

Packaging # NDC Package Description Multilevel Packaging 1 43093-105-01 1 KIT In 1 KIT None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, GLASS   10.5 g Part 2 1 BOTTLE, PLASTIC   420 mL

Part 1 of 2 GABAPENTIN  gabapentin   powder, for suspension

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Gabapentin (Gabapentin) Gabapentin 10.5 g  in 10.5 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10.5 g In 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/15/2010

Part 2 of 2 ORAL SUSPENSION VEHICLE  suspension   liquid

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength No Active Ingredients Found

Inactive Ingredients Ingredient Name Strength Water   Banana   N-Acetylglucosamine   Strawberry   ALTHAEA OFFICINALIS LEAF   Glycerin   Stevia Leaf   Acesulfame Potassium   Xanthan Gum   GLYCYRRHIZIN, AMMONIATED   Saccharin Sodium   Potassium Sorbate   Sodium Benzoate   Sodium Phosphate, Dibasic

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 420 mL In 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/15/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/15/2010

Labeler - Fusion Pharmaceuticals LLC (021420944)

Establishment
Name	Address	ID/FEI	Operations
Fusion Pharmaceuticals LLC		021420944	manufacture

Revised: 05/2010Fusion Pharmaceuticals LLC