Synthamin

Manufacturer
Baxter Healthcare Corporation | Baxter Healthcare Ltd
Effective date
2020-06-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:42:07

Label at a glance#

ProductSynthamin
Active ingredientLEUCINE, ISOLEUCINE, LYSINE, VALINE, PHENYLALANINE, HISTIDINE, THREONINE, METHIONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, SERINE, TYROSINE
Label structure2 sections

Label contents#

Full prescribing information#

HEALTH CARE PROVIDER LETTER

HEALTH CARE PROVIDER LETTER SECTION

Dear Healthcare Provider Letter image 1
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Shortage Synthamin Container Label
Drug Shortage Synthamin Container Label

Code FKB6642
3000 ml

Baxter Logo

SYNTHAMIN 17 without Electrolytes

10% Amino Acid Intravenous Infusion
VIAFLEX container

Hypertonic

POM symbol

Sterile, nonpyrogenic

Formula per 1000 ml

Essential amino acids
L-Leucine 7.30 g
L-Isoleucine 6.00 g
L-Lycine (as hydrochloride salt) 5.80 g
L-Valine 5.80 g
L-Phenylatanine 5.80 g
L-Histidine 4.80 g
L-Threonine 4.20 g
L-Methionine 4.00 g
L-Trypotophan 1.80 g

Other Ingredients
Water for injections QS
Sodium Acetate pH Adj
Glacial Acetic Acid pH Adj

Non-essential amino acids
L-Alanine 20.70 g
L-Arginine 11.50 g
Amino acetic Acid (glycine) 10.30 g
L-Proline 6.80 g
L-Serine 5.00 g
L-Tyrosine 400 mg
Total nitrogen per litre (approx) 18.5 g

mmol per litre (approx.)
Acetate 82
Chloride 40
balanced by ions from amino acids

Bulk source container for pharmacy use
Not for direct intravenous infusion

Refer to operating instructions for Automix high speed compounders before
use

For use under medical supervision
Do not use unless solution is clear and colourless or slightly yellow, and
container is undamaged
Check additive compatibility before use
It is not recommended that additions are made to this container
Do not administer simultaneously with blood
Discontinue infusion if adverse reaction occurs

Do not store above 25°C
Protect from light during storage
Keep out of the sight and reach of children
For single use only Discard any usused portion
Discard all equipment after use
Do not reconnect partially used bags

Baxter Healthcare Ltd
Caxton Way Thetford Norfolk IP24 3SE

PL 00116/0296
TH-35-01-970

LOT
EXP

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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9575-03ML - Milliliter0338-95758b6c35f1-4453-4a3b-bf0b-6acaf0e08d6b12018-01-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0338-95750338-9575-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
97a316be-3f08-42f2-bd25-b1e721276aa43d0063d8-d404-4d4a-abff-8b1adf5100422020-06-30Exact identifier
spl id: 97a316be-3f08-42f2-bd25-b1e721276aa4
spl set id: 3d0063d8-d404-4d4a-abff-8b1adf510042

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.