TrophAmine (Page 4 of 4)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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.

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 HCI•H2 0 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
(click image for full-size original)

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 LabelEntry Label
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 Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-1933
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOLEUCINE (ISOLEUCINE) ISOLEUCINE 0.82 g in 100 mL
LEUCINE (LEUCINE) LEUCINE 1.4 g in 100 mL
LYSINE ACETATE (LYSINE) LYSINE 1.2 g in 100 mL
METHIONINE (METHIONINE) METHIONINE 0.34 g in 100 mL
PHENYLALANINE (PHENYLALANINE) PHENYLALANINE 0.48 g in 100 mL
THREONINE (THREONINE) THREONINE 0.42 g in 100 mL
TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 0.2 g in 100 mL
VALINE (VALINE) VALINE 0.78 g in 100 mL
CYSTEINE HYDROCHLORIDE (CYSTEINE) CYSTEINE 0.024 g in 100 mL
HISTIDINE (HISTIDINE) HISTIDINE 0.48 g in 100 mL
TYROSINE (TYROSINE) TYROSINE 0.044 g in 100 mL
ACETYL L-TYROSINE (ACETYL L-TYROSINE) ACETYL L-TYROSINE 0.24 g in 100 mL
ALANINE (ALANINE) ALANINE 0.54 g in 100 mL
ARGININE (ARGININE) ARGININE 1.2 g in 100 mL
PROLINE (PROLINE) PROLINE 0.68 g in 100 mL
SERINE (SERINE) SERINE 0.38 g in 100 mL
GLYCINE (GLYCINE) GLYCINE 0.36 g in 100 mL
ASPARTIC ACID (ASPARTIC ACID) ASPARTIC ACID 0.32 g in 100 mL
GLUTAMIC ACID (GLUTAMIC ACID) GLUTAMIC ACID 0.5 g in 100 mL
TAURINE (TAURINE) TAURINE 0.025 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ACETIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0264-1933-10 12 CONTAINER in 1 CASE contains a CONTAINER
1 500 mL in 1 CONTAINER This package is contained within the CASE (0264-1933-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019018 10/27/2020
Labeler — B. Braun Medical Inc. (002397347)

Revised: 08/2022 B. Braun Medical Inc.

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