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

Synthamin by

Drug Labeling and Warnings

Synthamin by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter Healthcare Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CARE PROVIDER LETTER

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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
2100
1800
1500
1200
900
600
300

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9575
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C)	LEUCINE	7.30 g  in 1000 mL
ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)	ISOLEUCINE	6 g  in 1000 mL
LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6)	LYSINE	5.80 g  in 1000 mL
VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7)	VALINE	5.80 g  in 1000 mL
PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R)	PHENYLALANINE	5.60 g  in 1000 mL
HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E)	HISTIDINE	4.80 g  in 1000 mL
THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S)	THREONINE	4.20 g  in 1000 mL
METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL)	METHIONINE	4 g  in 1000 mL
TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX)	TRYPTOPHAN	1.80 g  in 1000 mL
ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX)	ALANINE	20.70 g  in 1000 mL
ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F)	ARGININE	11.50 g  in 1000 mL
GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C)	GLYCINE	10.30 g  in 1000 mL
PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V)	PROLINE	6.80 g  in 1000 mL
SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402)	SERINE	5 g  in 1000 mL
TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U)	TYROSINE	400 mg  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM ACETATE (UNII: 4550K0SC9B)
ACETIC ACID (UNII: Q40Q9N063P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9575-03	3 in 1 CARTON	11/03/2017	06/30/2020
1		3000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		11/03/2017	06/30/2020

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Ltd		221478644	ANALYSIS(0338-9575) , MANUFACTURE(0338-9575) , LABEL(0338-9575) , PACK(0338-9575) , STERILIZE(0338-9575)