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Fanatrex (Fusion Pharmaceuticals LLC)

Available Formats

Dosage Form Package Information Links
KIT 1 KIT in 1 KIT (43093-105-01) * 10.5 g in 1 BOTTLE, GLASS * 420 mL in 1 BOTTLE, PLASTIC Label Information

Complete Fanatrex Information

  • DESCRIPTION

    NDC 43093-105-01

    Rx only

    FusePaqâ„¢

    FANATREXâ„¢

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



    FusePaqâ„¢ 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

    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

    FusePaqâ„¢  Kit for Oral Suspension
    Fanatrexâ„¢
    (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 Box


  • INGREDIENTS AND APPEARANCE
    FANATREX 
    gabapentin kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43093-105
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43093-105-01 1 in 1 KIT
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 10.5 g  in 10.5 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 10.5 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    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
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    BANANA (UNII: 4AJZ4765R9)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    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 - California Pharmaceuticals LLC (021420944)
    Establishment
    Name Address ID/FEI Business Operations
    California Pharmaceuticals LLC 021420944 manufacture(43093-105)