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:

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

Gabapentin Label

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

Suspension Label

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:


Inactive Ingredients:


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

U.S. Patents Pending

CS72-A1 rev 0

Fanatrex Box


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: 05/2010 Fusion Pharmaceuticals LLC