AMINOSYN II isoleucine lysine acetate methionine phenylalanine threonine tryptophan valine arginine aspartic acid glutamic histi

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

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Productkenmerken Productkenmerken (SPC)
14-05-2018

Werkstoffen:

ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)

Beschikbaar vanaf:

Hospira, Inc.

INN (Algemene Internationale Benaming):

ISOLEUCINE

Samenstelling:

ISOLEUCINE 990 mg in 100 mL

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

New Drug Application

Productkenmerken

                                AMINOSYN II- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE,
PHENYLALANINE, THREONINE,
TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID,
HISTIDINE, PROLINE, SERINE, N-
ACETYLTYROSINE, AND GLYCINE INJECTION, SOLUTION
HOSPIRA, INC.
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AMINOSYN II
_AN AMINO ACID INJECTION_
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION.
FLEXIBLE PLASTIC CONTAINER
R only
DESCRIPTION
Aminosyn
II (an amino acid injection) is a sterile, nonpyrogenic solution for
intravenous infusion.
Aminosyn II is oxygen sensitive. The Pharmacy Bulk Package is a
sterile dosage form which contains
multiple single doses for use only in a pharmacy bulk admixture
program. The formulations are
described below:
ESSENTIAL AMINO ACIDS (MG/100 ML)
AMINOSYN II
10%
15%
Isoleucine
660
990
Leucine
1000
1500
Lysine (acetate)*
1050
1575
Methionine
172
258
Phenylalanine
298
447
Threonine
400
600
Tryptophan
200
300
Valine
500
750
*Amount cited is for lysine alone and does not include the acetate.
NONESSENTIAL AMINO ACIDS (MG/100 ML)
Alanine
993
1490
Arginine
1018
1527
L-Aspartic Acid
700
1050
L-Glutamic Acid
738
1107
Histidine
300
450
Proline
722
1083
Serine
530
795
N-Acetyl-L-Tyrosine
270
405
Glycine
500
750
OTHER CHARACTERISTICS
Protein Equivalent (approx. grams/liter)
100
150
®
x
®
Total Nitrogen (grams/liter)
15.3
23.0
Osmolarity (mOsmol/liter, actual)
870
1300
pH
5.8 (5.0 − 6.5)
5.8 (5.0 − 6.5)
Specific Gravity
1.03
1.05
Electrolytes (mEq/L)
Sodium (Na )
39.8
58.1
Acetate (C H O )
71.8
107.6
Sodium Hydrosulfite (mg/100mL)
20
20
Solution contains sodium hydroxide for pH adjustment.
Figure includes Na from the antioxidant, sodium hydrosulfite and from
the pH adjustor.
Includes acetate from lysine acetate.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride. Water can
permeate from inside the container into the overwrap but not in
amounts to affect the solution
significantly. Solutions in contact with the plastic container may
leach out certain chemical components
from the plastic in very sma
                                
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