SYNTHAMIN- leucine, isoleucine, lysine, valine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, arginine, glycine, proline, serine, tyrosine injection, solution 
Baxter Healthcare Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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SYNTHAMIN 17 without Electrolytes

HEALTH CARE PROVIDER LETTER

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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

2700
2400
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300

SYNTHAMIN 
leucine, isoleucine, lysine, valine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, arginine, glycine, proline, serine, tyrosine injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9575
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE7.30 g  in 1000 mL
ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE6 g  in 1000 mL
LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE5.80 g  in 1000 mL
VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE5.80 g  in 1000 mL
PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE5.60 g  in 1000 mL
HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE4.80 g  in 1000 mL
THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE4.20 g  in 1000 mL
METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE4 g  in 1000 mL
TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN1.80 g  in 1000 mL
ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE20.70 g  in 1000 mL
ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE11.50 g  in 1000 mL
GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE10.30 g  in 1000 mL
PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE6.80 g  in 1000 mL
SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE5 g  in 1000 mL
TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE400 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
ACETIC ACID (UNII: Q40Q9N063P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-9575-033 in 1 CARTON11/03/201706/30/2020
13000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage11/03/201706/30/2020
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare Ltd221478644ANALYSIS(0338-9575) , MANUFACTURE(0338-9575) , LABEL(0338-9575) , PACK(0338-9575) , STERILIZE(0338-9575)

Revised: 6/2020
 
Baxter Healthcare Corporation