TROPHAMINE- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, cysteine hydrochloride, histidine, tyrosine, n-acetyl-tyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, glutamic acid, and taurine solution

TrophAmine by

Drug Labeling and Warnings

TrophAmine by is a Prescription medication manufactured, distributed, or labeled by B. Braun Medical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • HOW SUPPLIED

    TrophAmine® pharmacy bulk package is supplied sterile and nonpyrogenic in 500 mL flexible plastic bags, packaged 12 per case.

    NDCREFSize
     0264-1933-10 S9333 500 mL

    Not made with natural rubber latex, DEHP or PVC.

    Storage

    Store in the closed corrugated case; do not expose TrophAmine® and/or TrophAmine®-containing admixed parenteral nutrition (PN) solution to light. Do not remove container from overwrap until ready to use. Do not use if overwrap has been opened or damaged. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Solution that has been frozen must not be used.

  • SPL UNCLASSIFIED SECTION

    Rx only

    TrophAmine is a registered trademark of B. Braun Medical Inc.

  • Preparation Instructions for TrophAmine®

    Caution: TrophAmine® Pharmacy Bulk Package is intended for intravenous infusion after further dilution only.

    Do not expose TrophAmine® and/or TrophAmine®-containing admixed parenteral nutrition (PN) solution to light.

    The pharmacy bulk package is for use in a Pharmacy Admixture Service only. Use of this product is restricted to a suitable work area, such as a laminar flow hood (or an equivalent clean air compounding area).

    Designed for use with an unvented sterile dispensing set.

    Step 1: Inspect Pharmacy Bulk Package overwrap and primary bag and do not use if damaged. Inspect oxygen indicator and do not use if oxygen indicator is pink or dark pink. Use only if container and seals are intact.

    Step 1 illustration

    Step 2: To open, tear overwrap starting from the tear notches (Figure 1). Remove TrophAmine® Pharmacy Bulk Package bag from overwrap and discard oxygen indicator, oxygen absorber and overwrap.

    Step 2 Figure 1 illustration
    Step 3: Inspect TrophAmine® Pharmacy Bulk Package bag visually (Figure 2). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect TrophAmine® for cloudiness, haze or particulate matter in good lighting. Discard the bag if any particulates or discoloration are observed.

    Step 3 Figure 2 Illustration

    Bag Hanger Illustration

    Step 4:  Remove aluminum foil of set port at the bottom of the Pharmacy Bulk Package bag (Figure 3a) and attach an unvented sterile dispensing set (Figure 3b).

    Step 4 Figure 3a 3b Illustration

    The set port may be penetrated only one time, utilizing a suitable sterile dispensing set which allows measured dispensing of the contents.

    The withdrawal of container contents should be accomplished without delay using aseptic technique. Discard container no later than 4 hours after initial closure puncture.

    Use of a syringe with needle is not recommended. Multiple entries increase the potential of the microbial and particulate contamination.

  • SPL UNCLASSIFIED SECTION

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862
    Made in Germany

    Revised: June 2022

    LD-625-2

  • PRINCIPAL DISPLAY PANEL - 500 mL Container Label

    TrophAmine®
    (10% Amino Acid Injection)

    NDC: 0264-1933-10

    REF S9333

    500 mL

    Protect from light.

    For Intravenous Infusion After Dilution

    852/12627204/0522

    LOT
    EXP:
    SN:

    Recommended Storage: Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Solution that has been frozen must not be used. Do not expose to light. See package insert for Dosage and Administration.

    PHARMACY BULK PACKAGE  -
    NOT FOR DIRECT INFUSION

    Each 100 mL contains:

     Essential Amino Acids 
     Isoleucine USP 0.82 g 
     Leucine USP  1.4 g
     Lysine  0.82 g
     (added as Lysine Acetate USP  1.2 g)
     Methionine USP  0.34 g
     Phenylalanine USP  0.48 g
     Threonine USP  0.42 g
     Tryptophan USP  0.2 g
     Valine USP  0.78 g
     Cysteine  <0.016 g
     (as Cysteine HCIH20 USP  <0.024 g)
     Histidine USP  0.48 g
     Tyrosine  0.24 g
     (added as Tyrosine USP  0.044 g
     and N-Acetyl-L-Tyrosine  0.24 g)

    Affix accompanying label for date and time of entry

    Nonessential Amino Acids
    Alanine USP 0.54 g
    Arginine USP1.2 g
    Proline USP 0.68 g
    Serine USP 0.38 g
    Glycine USP 0.36 g
    L-Aspartic Acid 0.32 g
    L-Glutamic Acid 0.5 g
    Taurine 0.025 g

    Water for Injection USP qs
    pH adjusted with Glacial Acetic Acid USP
    pH: 5.5 (5.0-6.0)
    Calc. Osmolarity: 866 mOsmol/liter

    Electrolytes (mEq/liter):
    Chloride <3
    Acetate 96.2 (see Package Insert)

    Sterile, nonpyrogenic.
    Single dose container.
    Use only if bag and seal are undamaged and solution is clear.
    Do not remove container from overwrap until ready to use.

    Recycle symbol

    Do not use if overwrap has been opened or damaged.
    For intravenous infusion after dilution.
    Not made with natural rubber latex, DEHP or PVC.
    Rx only
    TrophAmine is a registered trademark of B. Braun Medical Inc.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862
    Made in Germany

    LD-626-2 

    S9333 Container Label
  • PRINCIPAL DISPLAY PANEL - Accompanying 500 mL Bag Label

    Date of Entry:___/____/_____

    Time of Entry:____________________AM/PM

    Discard______hours after initial entry

    LD-628-1

    0/12627207/0419

    Entry Label
  • INGREDIENTS AND APPEARANCE
    TROPHAMINE 
    isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, cysteine hydrochloride, histidine, tyrosine, n-acetyl-tyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, glutamic acid, and taurine solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0264-1933
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE0.82 g  in 100 mL
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE1.4 g  in 100 mL
    LYSINE ACETATE (UNII: TTL6G7LIWZ) (LYSINE - UNII:K3Z4F929H6) LYSINE1.2 g  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE0.34 g  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE0.48 g  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE0.42 g  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN0.2 g  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE0.78 g  in 100 mL
    CYSTEINE HYDROCHLORIDE (UNII: ZT934N0X4W) (CYSTEINE - UNII:K848JZ4886) CYSTEINE0.024 g  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE0.48 g  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE0.044 g  in 100 mL
    ACETYL L-TYROSINE (UNII: DA8G610ZO5) (ACETYL L-TYROSINE - UNII:DA8G610ZO5) ACETYL L-TYROSINE0.24 g  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE0.54 g  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE1.2 g  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE0.68 g  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE0.38 g  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE0.36 g  in 100 mL
    ASPARTIC ACID (UNII: 30KYC7MIAI) (ASPARTIC ACID - UNII:30KYC7MIAI) ASPARTIC ACID0.32 g  in 100 mL
    GLUTAMIC ACID (UNII: 3KX376GY7L) (GLUTAMIC ACID - UNII:3KX376GY7L) GLUTAMIC ACID0.5 g  in 100 mL
    TAURINE (UNII: 1EQV5MLY3D) (TAURINE - UNII:1EQV5MLY3D) TAURINE0.025 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0264-1933-1012 in 1 CASE10/27/2020
    1500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01901810/27/2020
    Labeler - B. Braun Medical Inc. (002397347)

  • Trademark Results [TrophAmine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TROPHAMINE
    TROPHAMINE
    78672902 not registered Dead/Abandoned
    B. Braun Medical, Inc.
    2005-07-18
    TROPHAMINE
    TROPHAMINE
    73425189 1281249 Live/Registered
    American Hospital Supply Corporation
    1983-05-09

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